fda
616 records
FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20250903
Kits contain SureStep Foley Tray Systems recalled by BD that include incorrect product information insert sheets. If a mislabeled tray is used, patien | Product: Medline Kits containing BD SureStep Fo...
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FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20250903
Affected kits contain recalled Stryker Color Cuff Sterile Disposable Tourniquet Cuffs. Stryker Instruments initiated this recall due to a potential ma | Product: The Medline General Surgery Tray is cu...
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FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class I
20250903
Specific lots of reprocessed electrophysiology catheters may contain small residual particulates. | Product: Medline ReNewal Reprocessed St. Jude Medical Response and Supreme Diagnostic Electrophysiol...
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FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20250730
Affected convenience kits contain BD ChloraPrep Clear - 1 mL Applicators, which were recalled by BD due to potential to exhibit an open seal on its pa | Product: Medline Convenience Kits, containing B...
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FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class I
20250611
Affected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequate welds on specific lots. Perforators with inadequat | Product: Medline Kits containing Codman Disposa...
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FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20250423
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. | Product: Medline Convenience kits used for various procedures: 1) NAIL ...
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FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20250423
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. | Product: Medline Convenience kits used for various procedures: 1) ED CR...
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FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20250423
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. | Product: Refer to RES
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FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20250423
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. | Product: Medline Convenience kits used for various procedures: 1) CW PE...
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FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20250423
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. | Product: Medline Convenience kits used for various procedures: 1) T&A E...
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FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20250402
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues | Product: Medline procedure kits labeled as: ...
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FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20250402
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues | Product: Medline procedure kits labeled as: ...
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FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20250402
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues | Product: Medline procedure kits labeled as: ...
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FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20250402
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues | Product: Medline procedure kits labeled as: ...
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FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20250326
Potential breach in pouch packaging which could lead to loss of sterility. | Product: Proxima Drape labeled as PACK,BASIC,SIRUS,V,5/CS; PACK,BASIC IV,SIRUS,5/CS; PACK,SET UP,NO DRAPE,12/
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FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class I
20250205
The catheter subassembly in the Integrated Arterial Catheter was manufactured with excess material on the catheter hub. | Product: Medline General Surgery Tray kits: 1) ARTERIAL LINE TRAY, Item Numbe...
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FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20250108
Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endot | Product: Medline custom medical procedure kits ...
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FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20250108
Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endot | Product: Medline custom medical procedure kits ...
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FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20250101
Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infectio | Product: ST REPROCESSED BRUNS CURETTE #00 (BC00...
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FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20250101
Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within t | Product: KIT,SPINE LH Convenience kit, SKU DYNJ...
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FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20250101
Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within t | Product: SEPTOPLASTY PACK Convenient kit, SKU D...
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FDA Device Recall: Medline medical convenience kits labeled as: 1. ADULT INTUBATION TRAY, Kit Nu
2025-10-01
Class I — Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Flexicare BritePro Solo Fiber Optic Laryngoscope Handles due to the failure of the light...
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FDA Drug Recall: Good Neighbor Pharmacy, Alcohol Prep Pads, Distributed By AmeriSource Bergen, 1
2025-09-03
Class II — Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
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FDA Drug Recall: CURAD Alcohol Prep Pads, Sterile, Medium, 2-Ply, Contents: 5 boxes per Carton, 3
2025-09-03
Class II — Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
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FDA Drug Recall: ReliOn, Sterile Alcohol Swabs, Skin Cleanser, 200 Swabs, Distributed by, Walmart
2025-09-03
Class II — Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
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FDA Drug Recall: Medline Alcohol Prep Pads, 70% Isopropyl Alcohol, 100 Sterile 2-Ply Pads, Single
2025-09-03
Class II — Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
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FDA Drug Recall: RITE AID PHARMACY, first aid alcohol prep pads, DISTRIBUTED BY: RITE AID. 200 NE
2025-09-03
Class II — Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
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FDA Drug Recall: H-E-B, inControl, Sterile* Alcohol Pads, CONT. 100 PADS, Packaged in China with
2025-09-03
Class II — Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
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FDA Device Recall: Medline Kits containing BD SureStep Foley Tray Systems: SKU/Description: C
2025-09-03
Class II — Kits contain SureStep Foley Tray Systems recalled by BD that include incorrect product information insert sheets. If a mislabeled tray is used, patient risk ranges from minor injury to inju...
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FDA Device Recall: The Medline General Surgery Tray is customized to meet requirements of the hospi
2025-09-03
Class II — Affected kits contain recalled Stryker Color Cuff Sterile Disposable Tourniquet Cuffs. Stryker Instruments initiated this recall due to a potential manufacturing defect in which the flange ...
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FDA Device Recall: Medline ReNewal Reprocessed St. Jude Medical Response and Supreme Diagnostic Ele
2025-09-03
Class I — Specific lots of reprocessed electrophysiology catheters may contain small residual particulates.
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FDA Device Recall: Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, label
2025-07-30
Class II — Affected convenience kits contain BD ChloraPrep Clear - 1 mL Applicators, which were recalled by BD due to potential to exhibit an open seal on its packaging. This may constitute a breach t...
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FDA Device Recall: Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, label
2025-07-30
Class II — Affected convenience kits contain BD ChloraPrep Clear - 1 mL Applicators, which were recalled by BD due to potential to exhibit an open seal on its packaging. This may constitute a breach t...
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FDA Device Recall: Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, label
2025-07-30
Class II — Affected convenience kits contain BD ChloraPrep Clear - 1 mL Applicators, which were recalled by BD due to potential to exhibit an open seal on its packaging. This may constitute a breach t...
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FDA Device Recall: Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, label
2025-07-30
Class II — Affected convenience kits contain BD ChloraPrep Clear - 1 mL Applicators, which were recalled by BD due to potential to exhibit an open seal on its packaging. This may constitute a breach t...
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FDA Device Recall: Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22
2025-07-09
Class II — Medline Industries, LP. is issuing a recall for specific Medline kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN which was identified that during insertion of the ...
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FDA Device Recall: Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22
2025-07-09
Class II — Medline Industries, LP. is issuing a recall for specific Medline kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN which was identified that during insertion of the ...
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FDA Device Recall: Medline UMBILICAL TRAY W/3.5&5FR CATH, REF UVT1250
2025-07-02
Class II — There is a possible packaging defect impacting the outer Tyvec pouch that protects the sterile product.
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FDA Device Recall: Medline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI ADD A PA
2025-06-11
Class I — Affected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequate welds on specific lots. Perforators with inadequate welds may break or separate.
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FDA Device Recall: Medline Kits containing Codman Disposable Perforator 14 mm: CRANIOTOMY, SKU D
2025-06-11
Class I — Affected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequate welds on specific lots. Perforators with inadequate welds may break or separate.
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FDA Device Recall: Centurion Sterile Weitlaner Retractor 3 x 4 Prong, Reorder: I68395
2025-05-21
Class II — Three is the potential for the retractors to puncture through the sterile packaging.
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FDA Device Recall: Meridian Bioscience ImmunoCard STAT! Crypto/Giardia Test Kits, Model Number 7508
2025-05-14
Class II — A single lot of the ImmunoCard STAT! Crypto/Giardia Test Kit was inadvertently stored in Medline warehouses at temperatures outside of the labeled storage requirements.
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FDA Device Recall: Medline procedure kits, labeled as: T AND A PACK -LF, REF DYNJ85792
2025-05-07
Class II — It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.
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FDA Device Recall: Medline procedure kits, labeled as: 1) STERILE PREP KIT, REF DYNDA1359A; 2)
2025-05-07
Class II — It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.
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FDA Device Recall: Medline Sterile 0.9% Normal Saline, USP, 100mL, REF RDI30296
2025-05-07
Class II — It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.
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FDA Device Recall: Medline Sterile Water, USP, 100mL, REF RDI30295
2025-05-07
Class II — It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.
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FDA Device Recall: Medline procedure kits, labeled as: REDDY JOINT BATH, REF MMJB001A
2025-05-07
Class II — It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.
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FDA Device Recall: Medline Convenience kits used for various procedures: 1) NAIL PACK, Model Numbe
2025-04-23
Class II — There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
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FDA Device Recall: Medline Convenience kits used for various procedures: 1) ED CRASH C-SECTION TRA
2025-04-23
Class II — There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
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FDA Device Recall: Refer to RES
2025-04-23
Class II — There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
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FDA Device Recall: Medline Convenience kits used for various procedures: 1) CW PERI GYN, Model Num
2025-04-23
Class II — There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
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FDA Device Recall: Medline Convenience kits used for various procedures: 1) T&A ENDO PACK, Model N
2025-04-23
Class II — There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
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FDA Device Recall: Medline Convenience kits used for various procedures: 1) RHINOPLASTY PACK, Mode
2025-04-23
Class II — There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
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FDA Device Recall: Medline Convenience kits used for various procedures: 1) LABOR AND DELIVERY PAC
2025-04-23
Class II — There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
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FDA Device Recall: Medline Convenience kits used for various procedures: 1) DENTAL PACK-LF, Model
2025-04-23
Class II — There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
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FDA Device Recall: Medline Convenience kits used for various procedures: 1) MINOR BASIN -SMH, Mode
2025-04-23
Class II — There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
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FDA Device Recall: Medline Convenience kits used for various procedures: 1) STANDARD D&C, Model Nu
2025-04-23
Class II — There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
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FDA Device Recall: Medline Convenience kits used for various procedures: 1) NEURO PACK WRO-LF, Mod
2025-04-23
Class II — There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
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FDA Device Recall: Medline Convenience kits used for various procedures: 1) SKIN LESION SET, Model
2025-04-23
Class II — There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
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FDA Device Recall: Medline Convenience kits used for various procedures: 1) CUSTOM BLOCK KEMP PACK
2025-04-23
Class II — There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
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FDA Device Recall: Medline Convenience kits used for various procedures: 1) ARTHROSCOPIE DU GENOU-
2025-04-23
Class II — There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
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FDA Device Recall: Medline Convenience kits used for various procedures: 1) ANGIO CONSOLIDATED PAC
2025-04-23
Class II — There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
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FDA Device Recall: Medline Convenience kits used for various procedures: 1) LINE INSERTION PACK, M
2025-04-23
Class II — There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
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FDA Device Recall: Medline Convenience kits used for various procedures: 1) OCULOPLASTIC PICK PACK
2025-04-23
Class II — There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
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FDA Device Recall: Medline Convenience kits used for various procedures: 1) T A PACK, Model Numb
2025-04-23
Class II — There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
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FDA Device Recall: Medline Convenience kits used for various procedures: 1) CSTM PACEMAKER DRAPE P
2025-04-23
Class II — There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
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FDA Device Recall: MEDLINE ReNewal ENT Coblator II PROcise XP Wand,w/Integrated Cable Suction & Sal
2025-04-16
Class II — Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension.
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FDA Device Recall: MEDLINE ReNewal Coblator II ENT Evac 70 Xtra HP,w/Integrated Cable (Blue/Grey),
2025-04-16
Class II — Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension.
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FDA Device Recall: Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labele
2025-04-16
Class I — Medical convenience kits containing Medtronic Aortic Root Cannula are being recalled due to the potential excess material in the male lures on the aortic cannula.
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FDA Device Recall: Wayson Hydrocolloid Models: 1) MJ BANDAGE HYDROCOLLOID HEEL OVAL 6CT, Model Num
2025-04-16
Class II — There is a potential for the sterility of the device to be compromised.
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FDA Device Recall: MEDLINE ReNewal Coblator II Evac 70 Xtra Plasma Wand,w/Integrated Saline Line &
2025-04-16
Class II — Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension.
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FDA Device Recall: Medline procedure kits labeled as: 1) C SCOPE DISPOSABLE KIT, Pack Number 613
2025-04-02
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a r...
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FDA Device Recall: Medline procedure kits labeled as: 1) AV FISTULA PACK-LF, Pack Number DYNJ082
2025-04-02
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a r...
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FDA Device Recall: Medline procedure kits labeled as: 1) ANGIOGRAPHY SPECIALS
2025-04-02
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a r...
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FDA Device Recall: Medline procedure kits labeled as: 1) LACERATION TRAY, Pack Number DYNJ17328B
2025-04-02
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a r...
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FDA Device Recall: namic convenience kits labeled as: 1) MTS,4 VALVE,LFT,HRT,KIT-AHS-A*,NW, REF
2025-04-02
Class II — The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway.
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FDA Device Recall: Medline procedure kits labeled as: 1) ACOUSTIC NEUROMA PACK-LF, Pack Number D
2025-04-02
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a r...
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FDA Device Recall: Medline procedure kits labeled as: 1) ABLATION PACK, Pack Number DYNJ40629B;
2025-04-02
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a r...
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FDA Device Recall: Medline procedure kits labeled as: 1) BILLINGS CLINIC SC HEAD & NECK, Pack Num
2025-04-02
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a r...
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FDA Device Recall: Medline procedure kits labeled as: 1) CV NEONATAL PACK, Pack Number DYNJ67356
2025-04-02
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a r...
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FDA Device Recall: Medline procedure kits labeled as: 1) BILATERAL FACET TRAY, Pack Number DYNJRA0
2025-04-02
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a r...
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FDA Device Recall: Medline procedure kits labeled as: 1) AV FISTULA PACK, Pack Number DYNJ80088;
2025-04-02
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a r...
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FDA Device Recall: namic convenience kits labeled as: PML,72,ADULT,FLL-MLL,-,OEM, REF 80641722;
2025-04-02
Class II — The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway.
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FDA Device Recall: namic convenience kits labeled as: MTS,COLOR,PML,KIT,-,FRENCH HOSPITAL PG; me
2025-04-02
Class II — The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway.
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FDA Device Recall: Medline procedure kits labeled as: 1) CLOVIS ROBOTIC-LF, Pack Number DYNJ6106
2025-04-02
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a r...
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FDA Device Recall: Medline procedure kits labeled as: 1) DELIVERY PACK, Pack Number DYNJ0923016;
2025-04-02
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a r...
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FDA Device Recall: Medline procedure kits labeled as: 1) ARTHROSCOPY PACK, Pack Number DYNJHS010
2025-04-02
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a r...
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FDA Device Recall: Medline ReNewal Reprocessed Livewire Steerable Electrophysiology Catheters, Medl
2025-04-02
Class II — Devices may have higher than expected amounts of bacterial endotoxin.
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FDA Drug Recall: CURAD Alcohol Prep Pads, Sterile, Medium, 2-Ply, Contents: 5 boxes per Carton, 3
2025-03-26
Class II — Subpotent Drug
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FDA Drug Recall: Medline Alcohol Prep Pads, 70% Isopropyl Alcohol, 100 Sterile 2-Ply Pads, Single
2025-03-26
Class II — Subpotent Drug
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FDA Device Recall: Proxima Drape labeled as PACK,BASIC,SIRUS,V,5/CS; PACK,BASIC IV,SIRUS,5/CS; PACK
2025-03-26
Class II — Potential breach in pouch packaging which could lead to loss of sterility.
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FDA Device Recall: Proxima Drape labeled as ORTHO TRAUMA CDS, TOTAL KNEE AUX PACK, TOTAL HIP PACK,
2025-03-26
Class II — Potential breach in pouch packaging which could lead to loss of sterility.
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FDA Device Recall: Proxima Drape labeled as UNIVERSAL DAVINCI ROBOTIC P. Sterile surgical drape.
2025-03-26
Class II — Potential breach in pouch packaging which could lead to loss of sterility.
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FDA Device Recall: Proxima Drape labeled as HEAD AND NECK OSIS, WILLIS SHOULDER PACK, EXTREMITY PAC
2025-03-26
Class II — Potential breach in pouch packaging which could lead to loss of sterility.
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FDA Device Recall: Proxima Drape labeled as MINOR PACK and LAPAROSCOPY. Sterile surgical drape.
2025-03-26
Class II — Potential breach in pouch packaging which could lead to loss of sterility.
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FDA Device Recall: Medline Convenience Kits for Various Procedures: 1) ADULT INTUBATION TRAY, Mode
2025-02-26
Class II — Kits contain recalled components due to reports of reduced skin barrier wear time. This refers to a shorter duration that a skin barrier can effectively adhere to and protect the skin befor...
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FDA Device Recall: Medline RR-LIVER TRNS ACCESSORY PEDS, DUNJ63397; medical procedure convenience
2025-02-26
Class II — Medline is recalling medical convenience kits which were assembled with specific Coloplast Foley catheters and Prostatic catheters which were subsequently recalled due to a potential steril...
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FDA Device Recall: Medline General Surgery Tray kits: 1) ARTERIAL LINE TRAY, Item Number ART600;
2025-02-05
Class I — The catheter subassembly in the Integrated Arterial Catheter was manufactured with excess material on the catheter hub.
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FDA Device Recall: Medline procedure kits labeled as: 1) CENTRAL LINE DRESSING KIT, Reorder numb
2025-02-05
Class II — Certain Medline kits were manufactured and distributed with Procedure Masks with SO SOFT Earloops, and SOFT TOUCH II Surgical Masks which were subsequently recalled for not meeting the biob...
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FDA Device Recall: MEDLINE ARTERIAL LINE PACK, REF DYNJ65208B, medical convenience kit containing
2025-02-05
Class II — Certain lots Sterile Infusion Catheters which were mislabeled as having a heparin coating were either distributed or manufactured into medical convenience kits and distributed.
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FDA Device Recall: CENTURION Infusion Catheter, 7F, 17cm (DO), Reorder MIC17F7; Infusion Catheter w
2025-02-05
Class II — Certain lots Sterile Infusion Catheters which were mislabeled as having a heparin coating were either distributed or manufactured into medical convenience kits and distributed.
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FDA Device Recall: Medline procedure kits labeled as: 1) Port Access Kit, Reorder number CVI5130
2025-02-05
Class II — Certain Medline kits were manufactured and distributed with Procedure Masks with SO SOFT Earloops, and SOFT TOUCH II Surgical Masks which were subsequently recalled for not meeting the biob...
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FDA Device Recall: Medline Fluid Delivery Set with Drip Chamber: 1) MTO,135,YELLOW,MICRO,SPK-MAI
2025-01-22
Class I — Fluid Delivery Sets were incorrectly assembled with a white macro drip chamber instead of the required grey micro drip chamber. The macro drip chamber delivers three times more fluid per dro...
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FDA Device Recall: Medline custom medical procedure kits labeled as: 1) OPEN HEART CDS-LF, REFCD
2025-01-08
Class II — Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
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FDA Device Recall: Medline custom medical procedure kits labeled as: 1) ENSEMBLE RACHIS-LF, REF
2025-01-08
Class II — Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
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FDA Device Recall: Medline custom medical procedure kits labeled as: 1) CERVICAL PACK-LF, REF DY
2025-01-08
Class II — Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
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FDA Device Recall: See DocMan
2025-01-08
Class II — Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
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FDA Device Recall: Medline custom medical procedure kits labeled as: DEEP BRAIN STIMULATION PACK
2025-01-08
Class II — Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
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FDA Device Recall: Medline custom medical procedure kits labeled as: 1) VP SHUNT CDS, REF CDS983
2025-01-08
Class II — Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
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FDA Device Recall: Medline custom medical procedure kits labeled as: 1) CATH LAB PACK-LF, REF DY
2025-01-08
Class II — Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
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FDA Device Recall: Medline custom medical procedure kits labeled as: 1) MEM MAXILLOFACIAL PACK-L
2025-01-08
Class II — Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
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FDA Device Recall: Medline custom medical procedure kits labeled as: 1) MICRODISECTOMY PACK, REF
2025-01-08
Class II — Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
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FDA Device Recall: Medline custom medical procedure kits labeled as: 1) NASAL PACK, REF DYNJ6778
2025-01-08
Class II — Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
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FDA Device Recall: Medline custom medical procedure kits labeled as: 1) NEURO BASIN PACK-LF, REF
2025-01-08
Class II — Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
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FDA Device Recall: ST REPROCESSED BRUNS CURETTE #00 (BC00), Medline Item No. 67600K
2025-01-01
Class II — Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.
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FDA Device Recall: KIT,SPINE LH Convenience kit, SKU DYNJ906448A.
2025-01-01
Class II — Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile...
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FDA Device Recall: SEPTOPLASTY PACK Convenient kit, SKU DYNJ44759F. Convenience kits used for vari
2025-01-01
Class II — Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile...
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FDA Device Recall: ST OR MAYO HEGAR NEEDLEHOLDER 6"(OR2500), Medline Item No. 67870
2025-01-01
Class II — Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.
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FDA Device Recall: STERILE MAGILL FORCEP (MAGF9), Medline Item No. 66790
2025-01-01
Class II — Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.
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FDA Device Recall: Medline brand, medical procedure convenience kits, labeled as: 1) CRANIOTOMY, SK
2025-01-01
Class II — Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile...
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FDA Device Recall: O.R. SCISSORS, S/B, 5.5 STERILE, Medline Item No. DYND04000
2025-01-01
Class II — Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.
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FDA Device Recall: DIEP FLAP Convenience kit, SKU DYNJ910120. Convenience kits used for various pr
2025-01-01
Class II — Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile...
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FDA Device Recall: FESS-MB PACK-LF Convenience kit, SKU DYNJ0888159I. Convenience kits used for va
2025-01-01
Class II — Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile...
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FDA Device Recall: Medline brand, medical procedure convenience kits, labeled as: 1) MVFF/FIBU #54-
2025-01-01
Class II — Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile...
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FDA Device Recall: Medline brand, medical procedure convenience kits, labeled as: 1) SINUS CDS-1, S
2025-01-01
Class II — Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile...
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FDA Device Recall: Medline brand, medical procedure convenience kits, labeled as: 1) LAMINECTOMY C
2025-01-01
Class II — Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile...
View Source
FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20241225
Complaint defects have been noted regarding the adhesive elements of the device and the frame of the holder putting additional pressure on the patient | Product: HUDSON RCI mBrace, ET Tube Holder with...
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FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20241211
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryke | Product: MEDLINE convenience kits labeled as: ...
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FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20241211
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryke | Product: MEDLINE medical convenience kits label...
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FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20241211
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryke | Product: MEDLINE convenience kits labeled as: ...
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FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20241211
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryke | Product: MEDLINE convenience kits labeled as: ...
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FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20241211
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryke | Product: MEDLINE convenience kits labeled as: ...
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FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20241211
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryke | Product: MEDLINE convenience kits labeled as: ...
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FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20241211
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryke | Product: MEDLINE convenience kits labeled as: ...
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FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20241211
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryke | Product: MEDLINE convenience kits labeled as: ...
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FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20241204
The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position. | Product: MEDLINE procedure kits labeled as follows: 1) CONT EPI 20G W/HUSTEAD,...
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FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20241120
Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary t | Product: Lab Kit, SKU DYLAB1018; Component No. ...
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FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20241030
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-steri | Product: Medline brand medical procedure conven...
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FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20241030
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-steri | Product: Medline brand medical procedure conven...
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FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20241030
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-steri | Product: Medline brand medical procedure conven...
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FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20241030
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-steri | Product: Medline CHEST TUBE INSERTION TRAY ADUL...
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FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20241023
Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the DLP Vessel Cannulae. During manufacturing of the thr | Product: MEDLINE KIT CV I II, REF DYNJ906071B
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FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20240918
XXX | Product: Medline convenience kits containing semi-rigid suction liners labeled as follows: a) AMB VITRECTO
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FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20240918
Potential for an incomplete seal on the packaging tray. | Product: Medline ReNewal Reprocessed Covidien LigaSure Maryland Jaw Sealer/Divider, Nano-Coated, Compatible w
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FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20240918
Potential for an incomplete seal on the packaging tray. | Product: Medline ReNewal Reprocessed Covidien LigaSure Blunt Tip, Sealer/Divider, Nano-Coated, Compatible w/
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FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20240918
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issue | Product: Medline Convenience kits, labeled as: ...
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FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20240918
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issue | Product: Medline Convenience kits labeled as: ...
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FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20240918
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issue | Product: Medline Convenience kits labeled as: ...
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FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20240918
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issue | Product: Medline Convenience kits labeled as: ...
View Source
FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20240918
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issue | Product: Medline Convenience kits labeled as: ...
View Source
FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20240904
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issue | Product: Medline procedural kits labeled as: ...
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FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20240904
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issue | Product: Centurion procedure packs, containing...
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FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20240904
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issue | Product: see RES for description
View Source
FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20240904
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issue | Product: Medline procedural kits labeled as: ...
View Source
FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20240904
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issue | Product: Medline procedural kits labeled as: ...
View Source
FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20240904
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issue | Product: Medline procedure packs containing She...
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FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20240904
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issue | Product: Medline procedural kits labeled as: ...
View Source
FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20240904
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issue | Product: Centurion procedure kits labeled as: ...
View Source
FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20240904
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issue | Product: Medline procedural kits labeled as: ...
View Source
FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20240904
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issue | Product: Medline procedure packs containing She...
View Source
FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20240904
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issue | Product: Centurion procedure packs, containing ...
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FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20240828
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister. | Product: LINER, SOFT, SUCTION CANISTER, 1500CC, REF DYNDSCL1500
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FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20240828
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister. | Product: Medline medical procedure kits labeled as follows: a) HEART ANESTHESIA SET UP...
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FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class I
20240814
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issue | Product: Medline procedure kits labeled as: ...
View Source
FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20240710
Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fa | Product: Sterile convenience kits: a. Medli...
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FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20240612
It has been identified that testing documentation does not support that the syringes can successfully deliver accurate volumes across the full range o | Product: MEDLINE LUER SLIP DISPOSABLE SYRINGE W...
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FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20240522
Products have a lack of sterility assurance. | Product: Namic FLUID DELIVERY SET, REF 91300040
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FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20240410
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all u | Product: Centurion manual surgical kits labeled...
View Source
FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20240410
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all u | Product: Centurion DISP.UMBILICAL CORD CLAMP CU...
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FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20240410
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all u | Product: Centurion STERILE COTTON DENTAL ROLLS ...
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FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20240410
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all u | Product: Centurion Hemostat kits labeled as: ...
View Source
FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20240410
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all u | Product: MEDLINE SWABSTICKS PVP 3 PK, Product C...
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FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class I
20240306
Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Ch | Product: MEDLINE TRAY TRACH BASIC SOLUTION, REF...
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FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class I
20240306
Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Ch | Product: Medline Kits, trays, and packs labeled...
View Source
FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class I
20240306
Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Ch | Product: Medline Kits, trays, and packs labeled...
View Source
FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class I
20240306
Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Ch | Product: Centurion Kits, trays, and packs label...
View Source
FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class I
20240306
Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Ch | Product: Medline Kits, trays, and packs labeled...
View Source
FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class I
20240306
Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Ch | Product: MEDLINE Kits, trays, and packs labeled...
View Source
FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class I
20240306
Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Ch | Product: Medline Kits, trays, and packs labeled...
View Source
FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class I
20240306
Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Ch | Product: Medline Kits, trays, and packs labeled...
View Source
FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20240207
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood and Blood Culture Kits. This recall is due to kits b | Product: MEDLINE BLOOD CULTURE KIT, Reorder Num...
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FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20240207
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood and Blood Culture Kits. This recall is due to kits b | Product: MEDLINE BLOOD CULTURE KIT, Reorder Num...
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FDA Device Recall: HUDSON RCI mBrace, ET Tube Holder with 4 Point Head Strap, REF DYNJMBRC4; trache
2024-12-25
Class II — Complaint defects have been noted regarding the adhesive elements of the device and the frame of the holder putting additional pressure on the patient's cheekbones and upper lip which may c...
View Source
FDA Device Recall: HUDSON RCI mBrace, ET Tube Holder with Bite Block and 4 Point Head Strap, REF DY
2024-12-25
Class II — Complaint defects have been noted regarding the adhesive elements of the device and the frame of the holder putting additional pressure on the patient's cheekbones and upper lip which may c...
View Source
FDA Device Recall: HUDSON RCI mBrace, ET Tube Holder with Bite Block and 2 Point Head Strap, REF DY
2024-12-25
Class II — Complaint defects have been noted regarding the adhesive elements of the device and the frame of the holder putting additional pressure on the patient's cheekbones and upper lip which may c...
View Source
FDA Device Recall: HUDSON RCI mBrace, ET Tube Holder and 2 Point Head Strap, REF DYNJMBRC2; trachea
2024-12-25
Class II — Complaint defects have been noted regarding the adhesive elements of the device and the frame of the holder putting additional pressure on the patient's cheekbones and upper lip which may c...
View Source
FDA Device Recall: MEDLINE convenience kits labeled as: PORT INSERTION PACK, REF DYNJ81597
2024-12-11
Class II — Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
View Source
FDA Device Recall: MEDLINE medical convenience kits labeled as: 1) ACETABULAR PACK-LF, REF DYNJ0
2024-12-11
Class II — Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
View Source
FDA Device Recall: MEDLINE convenience kits labeled as: 1) ANGIO PACK #2, REFDYNJ39185D; 2) CV
2024-12-11
Class II — Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
View Source
FDA Device Recall: MEDLINE convenience kits labeled as: L&D MINOR PACK, REF DYNJ82672
2024-12-11
Class II — Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
View Source
FDA Device Recall: MEDLINE convenience kits labeled as: 1) C-SECTION OR 30 CDS, REF CDS820075V;
2024-12-11
Class II — Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
View Source
FDA Device Recall: MEDLINE convenience kits labeled as: COLON WOUND CLOSURE PACK, REF DYNJ52141B
2024-12-11
Class II — Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
View Source
FDA Device Recall: MEDLINE convenience kits labeled as: 1) MAJOR VASCULAR-LF, REF CDS840232L; 2)
2024-12-11
Class II — Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
View Source
FDA Device Recall: MEDLINE convenience kits labeled as: 1) BASIC NEURO PACK, REF CDS780202P; 2
2024-12-11
Class II — Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
View Source
FDA Device Recall: MEDLINE convenience kits labeled as: 1) BURN, REF CDS983465M; 2) BURN, REF
2024-12-11
Class II — Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
View Source
FDA Device Recall: MEDLINE convenience kits labeled as: 1) LAKELAND SINGLE BASIN PACK-LF, REF DY
2024-12-11
Class II — Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
View Source
FDA Device Recall: MEDLINE convenience kits labeled as: 1) GYN LAPAROSCOPY-LF, REF CDS760059I;
2024-12-11
Class II — Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
View Source
FDA Device Recall: MEDLINE convenience kits labeled as: 1) CIRCUMCISION PACK, REF DYNJ16826O;
2024-12-11
Class II — Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
View Source
FDA Device Recall: MEDLINE convenience kits labeled as: 1) TRACH TOTE, REF DYNJ85691; 2) TRACH
2024-12-11
Class II — Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
View Source
FDA Device Recall: MEDLINE convenience kits labeled as: 1) TOT/ GYN LITHOTOMY CDS, REF CDS985431
2024-12-11
Class II — Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
View Source
FDA Device Recall: MEDLINE convenience kits labeled as: 1) MAJOR LITHOTOMY CDS-LF, REF CDS760056
2024-12-11
Class II — Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
View Source
FDA Device Recall: MEDLINE convenience kits labeled as: 1) CVL PACK, REF DYNJ00281O; 2) VASCUL
2024-12-11
Class II — Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
View Source
FDA Device Recall: Refer to RES or lead review memo for complete list of affected reference/catalog
2024-12-11
Class II — Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
View Source
FDA Device Recall: MEDLINE convenience kits labeled as: 1) ORAL SURGERY PK RFID, REF DYNJ52404I
2024-12-11
Class II — Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
View Source
FDA Device Recall: MEDLINE convenience kits labeled as: 1) CLEAN CLOSING PACK, REF DYNJ80686A;
2024-12-11
Class II — Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
View Source
FDA Device Recall: MEDLINE convenience kits labeled as: 1) VAGINAL, REF CDS984955M; 2) DAY SUR
2024-12-11
Class II — Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
View Source
FDA Device Recall: MEDLINE convenience kits labeled as: 1) LITHOTOMY/PELVISCOPY PACK, REF DYNJ05
2024-12-11
Class II — Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
View Source
FDA Device Recall: MEDLINE convenience kits labeled as: 1) ZALE HEAD & NECK CDS, REF CDS983184I;
2024-12-11
Class II — Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
View Source
FDA Device Recall: MEDLINE convenience kits labeled as: 1) MINOR EYE TRAY #81, REF DYNJ27466S;
2024-12-11
Class II — Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
View Source
FDA Device Recall: MEDLINE procedure kits labeled as follows: 1) CONT EPI 20G W/HUSTEAD, REF PAIN
2024-12-04
Class II — The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.
View Source
FDA Device Recall: MEDLINE procedure kits labeled as follows: 1) 20G EPI CATH SINGLE STERILE, RE
2024-12-04
Class II — The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.
View Source
FDA Device Recall: (1) Medline Pacer Implant Pack, REF DYNJ59194A, 4 kits/case, sterile; and (2) M
2024-12-04
Class II — Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length.
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FDA Device Recall: MEDLINE procedure kits labeled as follows: 1) ECHOSTIM BLOCK SET, REF DYNJRA90
2024-12-04
Class II — The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.
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FDA Device Recall: (1) Medline Open Heart CDS, REF CDS840132O, packaged 1 kit/case, non-sterile; an
2024-12-04
Class II — Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length.
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FDA Device Recall: Medline Shoulder Repair Pack-LF, REF DYNJ82607, 2 kits/case, sterile.
2024-12-04
Class II — Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length.
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FDA Device Recall: MEDLINE procedure kits labeled as follows: 1) COMBINED SPINAL AND EPIDURAL, R
2024-12-04
Class II — The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.
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FDA Device Recall: MEDLINE procedure kits labeled as follows: 1) PERIPHERAL CONTINUOUS NERVE BL,
2024-12-04
Class II — The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.
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FDA Device Recall: Lab Kit, SKU DYLAB1018; Component No. 503581
2024-11-20
Class II — Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary treatment and/or prolonged hospitalizati...
View Source
FDA Device Recall: URINE COLLECTION VHC, SKU DYLAB1016; Component No. 503581
2024-11-20
Class II — Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary treatment and/or prolonged hospitalizati...
View Source
FDA Device Recall: Clean Catch Kit, SKU DYKM1833A; Component No. 503581
2024-11-20
Class II — Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary treatment and/or prolonged hospitalizati...
View Source
FDA Device Recall: CARROLLTON HIP FX Convenience kit used for surgical procedures, SKU SYNJ910003A
2024-11-20
Class II — Products within a Medline pack may be impacted by a packaging error in which an incomplete seal has formed on the packaging thereby creating a packaging seal gap.
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FDA Device Recall: UA KIT, SKU DYKM1690A; Component No. 503581
2024-11-20
Class II — Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary treatment and/or prolonged hospitalizati...
View Source
FDA Device Recall: URINE COLLECTION KIT, SKU DYKM1848A DYKM2005 DYKM2151 DYLAB1004 DYLAB1004A
2024-11-20
Class II — Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary treatment and/or prolonged hospitalizati...
View Source
FDA Device Recall: Medline brand medical procedure convenience kits, labeled as: a) LITHOTOMY PA
2024-10-30
Class II — It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the po...
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FDA Device Recall: Medline brand medical procedure convenience kits, labeled as: a) PLASTIC PACK
2024-10-30
Class II — It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the po...
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FDA Device Recall: Medline brand medical procedure convenience kits, labeled as: a) TRAY ADD A C
2024-10-30
Class II — It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the po...
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FDA Device Recall: Medline CHEST TUBE INSERTION TRAY ADUL, REF CHT1165; medical procedure convenien
2024-10-30
Class II — It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the po...
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FDA Device Recall: Medline DENTAL PACK, REF DYNJ64086B; medical procedure convenience kit
2024-10-30
Class II — It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the po...
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FDA Device Recall: Medline brand, medical procedure convenience kits, labeled as: a) CUH OPEN HE
2024-10-30
Class II — It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the po...
View Source
FDA Device Recall: Centurion OB TRAY, REF MNS13965A; medical procedure convenience kit
2024-10-30
Class II — It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the po...
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FDA Device Recall: Medline EYE PACK, REF LYN036EPESB; medical procedure convenience kit
2024-10-30
Class II — It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the po...
View Source
FDA Device Recall: Medline AMBULATORY MINI PACK, REF DYNJ82579; medical procedure convenience kit
2024-10-30
Class II — It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the po...
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FDA Device Recall: Medline brand medical procedure convenience kits, labeled as: 1) NEW LONDON T
2024-10-30
Class II — It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the po...
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FDA Device Recall: Medline brand medical procedure convenience kits, labeled as: 1) EYE PACK, REF
2024-10-30
Class II — It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the po...
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FDA Device Recall: Medline brand medical procedure convenience kit, labeled as: a) PAIN PROCEDURE
2024-10-30
Class II — It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the po...
View Source
FDA Device Recall: Medline DIALYSIS PACK, REF DYNJ36932A; medical procedure convenience kit
2024-10-30
Class II — It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the po...
View Source
FDA Device Recall: Centurion EP LAB INSTRUMENT KIT, REF MNS10480; medical procedure convenience kit
2024-10-30
Class II — It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the po...
View Source
FDA Device Recall: Medline CENTRAL CATHETER INSERTION TRA, REF CVI680C; medical procedure convenien
2024-10-30
Class II — It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the po...
View Source
FDA Device Recall: Medline TUBAL LIGATION PACK, REF DYNJ66230B; medical procedure convenience kit
2024-10-30
Class II — It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the po...
View Source
FDA Device Recall: Medline brand medical procedure convenience kits, labeled as: 1) THORACENTESIS T
2024-10-30
Class II — XXX
View Source
FDA Device Recall: Centurion PEDIATRIC/ADULT TRACHEOSTOMY T, REF TC7895; medical procedure convenie
2024-10-30
Class II — It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the po...
View Source
FDA Device Recall: Medline brand, medical procedure convenience kits, labeled as: a) RADIOLOGY L
2024-10-30
Class II — It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the po...
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FDA Device Recall: Medline brand medical procedure convenience kits, labeled as: a) UNIVERSAL DR
2024-10-30
Class II — It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the po...
View Source
FDA Device Recall: MEDLINE KIT CV I II, REF DYNJ906071B
2024-10-23
Class II — Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the DLP Vessel Cannulae. During manufacturing of the three listed lot numbers, product for mode...
View Source
FDA Device Recall: MEDLINE OPEN HEART, REF DYNJ904261B
2024-10-23
Class II — Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the DLP Vessel Cannulae. During manufacturing of the three listed lot numbers, product for mode...
View Source
FDA Device Recall: MEDLINE OPEN HEART PACK, REF DYNJ66216C
2024-10-23
Class II — Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the DLP Vessel Cannulae. During manufacturing of the three listed lot numbers, product for mode...
View Source
FDA Device Recall: MEDLINE HEART CABG CDS, REF CDS983376R
2024-10-23
Class II — Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the DLP Vessel Cannulae. During manufacturing of the three listed lot numbers, product for mode...
View Source
FDA Device Recall: Medline Sterile Laparoscopy Pack, DYNJ68187A (REF), containing the component Con
2024-10-16
Class II — CONMED Corporation (vendor) initiated a recall for select lot numbers of the Unimax Detachable Endo Pocket. The Detachable Endo Pocket is indicated for use as a receptacle for the collecti...
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FDA Device Recall: MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.
2024-10-16
Class II — It has been determined that certain Blood Pressure Monitors containing a faulty microchip have failed to power on or have shown display screen issues after the initial few uses, as well as ...
View Source
FDA Device Recall: MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
2024-10-16
Class II — It has been determined that certain Blood Pressure Monitors containing a faulty microchip have failed to power on or have shown display screen issues after the initial few uses, as well as ...
View Source
FDA Device Recall: Medline Contro-Bulb Syringe, REF DYND20125; bulb irrigation syringe
2024-09-25
Class II — Packaging material was updated for the Bulb Irrigation Syringe (DYND20125), and additional testing done at Medline Corporate indicated the potential for the sterile barrier to be breached d...
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FDA Device Recall: Medline convenience kits containing semi-rigid suction liners labeled as follows
2024-09-18
Class II — XXX
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FDA Device Recall: Medline ReNewal Reprocessed Covidien LigaSure Maryland Jaw Sealer/Divider, Nano-
2024-09-18
Class II — Potential for an incomplete seal on the packaging tray.
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FDA Device Recall: Medline ReNewal Reprocessed Covidien LigaSure Blunt Tip, Sealer/Divider, Nano-Co
2024-09-18
Class II — Potential for an incomplete seal on the packaging tray.
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FDA Device Recall: Medline Convenience kits, labeled as: 1) SUTURING SET PACK ASSY P791011, Pac
2024-09-18
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
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FDA Device Recall: Medline Convenience kits labeled as: 1) KIT MANIFOLD CSTM-NORTHRIDGE, Pack Nu
2024-09-18
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
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FDA Device Recall: Medline Convenience kits labeled as: 1) LABOR & DELIVERY CDS, Pack Number CDS8
2024-09-18
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
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FDA Device Recall: Medline Convenience kits labeled as: 1) ADMIT KIT , Pack Number DYKA1225B;
2024-09-18
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
View Source
FDA Device Recall: Medline Convenience kits labeled as: 1) CENTRAL LINE CDS, Pack Number CDS93009
2024-09-18
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
View Source
FDA Device Recall: Medline Convenience kits labeled as: 1) UROLOGY MINOR CDS , Pack Number CDS98
2024-09-18
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
View Source
FDA Device Recall: Medline Convenience kits labeled as: 1) STEREOTACTIC BREAST BIOPSY TRA, Pack
2024-09-18
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
View Source
FDA Device Recall: Medline convenience kits containing semi-rigid suction liners labeled as follows
2024-09-18
Class II — Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/2023 due to the potential los...
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FDA Device Recall: Medline Convenience kits labeled as: 1) NHP BREAST BIOPSY PACK, Pack Number D
2024-09-18
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
View Source
FDA Device Recall: Medline Convenience kits labeled as: 1) CYSTO PACK, Pack Number DYNJ42742D;
2024-09-18
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
View Source
FDA Device Recall: Medline Convenience kits, labeled as: 1) TRACHEOTOMY TRAY, Pack Number DYNDA1
2024-09-18
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
View Source
FDA Device Recall: Medline Convenience kits labeled as: 1) CVC INSERTION PACK, Pack Number CVI47
2024-09-18
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
View Source
FDA Device Recall: Medline ReNewal Reprocessed Covidien LigaSure Impact, Sealer/Divider, Nano-Coate
2024-09-18
Class II — Potential for an incomplete seal on the packaging tray.
View Source
FDA Device Recall: Medline Convenience kits labeled as: 1) EP DRAPE PACK-LF, Pack Number DYNJ020
2024-09-18
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
View Source
FDA Device Recall: Medline convenience kits containing semi-rigid suction liners labeled as follows
2024-09-18
Class II — Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/2023 due to the potential los...
View Source
FDA Device Recall: Medline convenience kits containing semi-rigid suction liners labeled as follows
2024-09-18
Class II — Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/2023 due to the potential los...
View Source
FDA Device Recall: Medline Convenience kits labeled as: 1) OR CLEAN UP KIT, Pack Number DYK10023
2024-09-18
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
View Source
FDA Device Recall: Medline Convenience kits labeled as: 1) PSP - VAMC LONG BEACH, Pack Number 14
2024-09-18
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
View Source
FDA Device Recall: Medline Convenience kits labeled as: HSG TRAY, Pack Number DYNDH1453
2024-09-18
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
View Source
FDA Device Recall: Medline Convenience kits labeled as: ADMIT KIT PILLOW BOX, Pack Number DYKA13
2024-09-18
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
View Source
FDA Device Recall: Medline convenience kits containing semi-rigid suction liners labeled as follows
2024-09-18
Class II — Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/2023 due to the potential los...
View Source
FDA Device Recall: CRANIOTOMY PACK, Pack Number DYNJ46552O
2024-09-18
Class II — A non-sterile Mastisol component, which was not labeled as being sterile or non-sterile, was placed in the non-sterile portion of certain sterile convenience kits and distributed. In the e...
View Source
FDA Device Recall: Medline Convenience kits labeled as: 1) SPECIAL PROCEDURE PACK ARTERI , Pack N
2024-09-18
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
View Source
FDA Device Recall: Medline Convenience kits labeled as: 1) CHEST TUBE INSERTION TRAY, Pack Numbe
2024-09-18
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
View Source
FDA Device Recall: Medline Convenience kits labeled as: KIT VASCULAR IVC FILTER PLACEM, Pack Num
2024-09-18
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
View Source
FDA Device Recall: Medline convenience kits containing semi-rigid suction liners labeled as follows
2024-09-18
Class II — Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/2023 due to the potential los...
View Source
FDA Device Recall: Medline Convenience kits labeled as: MUNCY PACK, Pack Number DYNJ03097D
2024-09-18
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
View Source
FDA Device Recall: Medline convenience kits containing semi-rigid suction liners labeled as follows
2024-09-18
Class II — Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/2023 due to the potential los...
View Source
FDA Device Recall: Medline Convenience kits labeled as: 1) 6" FEMORAL ARTERIAL LINE KIT- ICU, Pa
2024-09-18
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
View Source
FDA Device Recall: Medline convenience kits containing semi-rigid suction liners labeled as follows
2024-09-18
Class II — Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/2023 due to the potential los...
View Source
FDA Device Recall: Medline Convenience kits labeled as: 1) HEAD & NECK TRAY, Pack Number AM310B ;
2024-09-18
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
View Source
FDA Device Recall: Medline Convenience kits labeled as: 1) PUNCTURE TRAY , Pack Number 00-401649G
2024-09-18
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
View Source
FDA Device Recall: Medline Convenience kits, labeled as: GAMMA NAIL CDS-LF , Pack Number CDS98
2024-09-18
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
View Source
FDA Device Recall: Medline Convenience kits labeled as: SCS-LF, DYNJ902314D
2024-09-18
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
View Source
FDA Device Recall: Medline Convenience kits, labeled as: 1) SINGLE SHOT EPIDURAL PACK-LF, Pack Nu
2024-09-18
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
View Source
FDA Device Recall: Medline Convenience kits labeled as: TONSIL & ADENOID PACK, Pack Number DYNJ4
2024-09-18
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
View Source
FDA Device Recall: Medline Convenience kits labeled as: 1) DIALYSIS CATHETER INSERTION KIT, Pack
2024-09-18
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
View Source
FDA Device Recall: Medline Convenience kits, containing Shenli syringes, labeled as: 1) LOCAL PA
2024-09-18
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
View Source
FDA Device Recall: Medline Convenience kits labeled as: 1) MINOR BASIC PACK-LF, Pack Number DYNJ
2024-09-18
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
View Source
FDA Device Recall: Medline Convenience kits labeled as: 1) FILTER-.8 MICRON, Pack Number 2008;
2024-09-18
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
View Source
FDA Device Recall: Medline Convenience kits labeled as: 1) GROTH PELVISCOPY CDS, Pack Number CDS
2024-09-18
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
View Source
FDA Device Recall: Medline Convenience kits labeled as: 1) BIOPSY PROCEDURE PACK, Pack Number 00-
2024-09-18
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
View Source
FDA Device Recall: Medline Convenience kits, labeled as: 1) KNEE ARTHROSCOPY CDS-LF , Pack Numb
2024-09-18
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
View Source
FDA Device Recall: Medline convenience kits containing semi-rigid suction liners labeled as follows
2024-09-18
Class II — Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/2023 due to the potential los...
View Source
FDA Device Recall: Medline Convenience kits labeled as: 1) PREP TRAY, Pack Number DYNDA1540; 2
2024-09-18
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
View Source
FDA Device Recall: Medline Convenience kits labeled as: 1) CHEST TUBE TRAY , Pack Number CHT2120
2024-09-18
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
View Source
FDA Device Recall: Medline Convenience kits labeled as: PUH ESOPHAGECTOMY CDS, Pack Number CDS98
2024-09-18
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
View Source
FDA Device Recall: Medline Convenience kits labeled as: 1) CATH LAB SPECIAL PROCEDURE, Pack Numbe
2024-09-18
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
View Source
FDA Device Recall: Medline convenience kits labeled as: 1) ANGIOGRAPHY DRAPE PACK, Pack Number 00
2024-09-18
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
View Source
FDA Device Recall: Medline Convenience kits labeled as: 1) ANGIOGRAPHY DRAPE PACK, Pack Number 00
2024-09-18
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
View Source
FDA Device Recall: Medline convenience kits containing semi-rigid suction liners labeled as follows
2024-09-18
Class II — Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/2023 due to the potential los...
View Source
FDA Device Recall: Medline Convenience kits labeled as: 1) MYELOGRAM PACK, Pack Number 00-399025L
2024-09-18
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
View Source
FDA Device Recall: Medline Convenience kits, labeled as: 1) BLOOD CULTURE COLLECTION KIT, Pack
2024-09-18
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
View Source
FDA Device Recall: Medline convenience kits labeled as: 1) PERMANENT PACING, Pack Number 00-40036
2024-09-18
Class II — XXX
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FDA Device Recall: Medline Convenience kits labeled as: 1) SYRINGE CNTRL 10ML RED L/L LP , Pack
2024-09-18
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
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FDA Device Recall: Medline Convenience kits labeled as: 1) PACK VAGINAL DELIVERY , Pack Number AM
2024-09-18
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
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FDA Device Recall: Medline Convenience kits labeled as: 1) ADULT DRAWER 5, Pack Number ACC010647A
2024-09-18
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
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FDA Device Recall: Medline Convenience kits labeled as: 1) INFECTION DRIVELINE MANAGEMENT KIT, P
2024-09-18
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
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FDA Device Recall: Medline Convenience kits, labeled as: BIOPSY TRAY-LF, Pack Number DYNDH1229
2024-09-18
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
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FDA Device Recall: Medline Convenience kits labeled as: 1) SYR CONTROL PAD 12ML L/L, Pack Number
2024-09-18
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
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FDA Device Recall: Medline Convenience kits labeled as: 1) OFFICE PACK FOR HYSTEROSCOPY, Pack Num
2024-09-18
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
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FDA Device Recall: Medline Convenience kits labeled as: 1) OSTEOTOMY ORAL PROCEDURE, Pack Number
2024-09-18
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
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FDA Device Recall: Medline procedural kits labeled as: ARTHROGRAPH TRAY, Pack Number MNS12670A
2024-09-04
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
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FDA Device Recall: Centurion procedure packs, containing Caina syringes, labeled as: 1) ARTHROGRA
2024-09-04
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
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FDA Device Recall: see RES for description
2024-09-04
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
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FDA Device Recall: Medline procedural kits labeled as: 1) ANESTHESIA CIRCUIT PEDS-LF, Pack Numbe
2024-09-04
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
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FDA Device Recall: Medline procedural kits labeled as: 1) ARTHROGRAM TRAY, Pack Number MNS11965A
2024-09-04
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
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FDA Device Recall: Medline procedure packs containing Shenli syringes, labeled as follows: 1) DIAL
2024-09-04
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
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FDA Device Recall: Medline procedural kits labeled as: 1) OPEN HEART PEDS, Pack Number CDS981050
2024-09-04
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
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FDA Device Recall: Centurion procedure kits labeled as: 1) 3" RADIAL ARTERIAL LINE KIT- ICU, Pack
2024-09-04
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
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FDA Device Recall: Medline procedural kits labeled as: PREOP NERVE BLOCK TRAY, Pack Number DYNJR
2024-09-04
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
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FDA Device Recall: Medline procedure packs containing Shenli syringes, labeled as follows: 1) NE
2024-09-04
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
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FDA Device Recall: Centurion procedure packs, containing Caina syringes, labeled as: 1) NICU CIR
2024-09-04
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
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FDA Device Recall: Centurion procedure packs, containing Caina syringes, labeled as: 1) ARTHROG
2024-09-04
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
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FDA Device Recall: Medline Convenience kits, labeled as: 1) NERVE STIMULATOR, Pack Number CDS9815
2024-09-04
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
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FDA Device Recall: Centurion procedure packs, labeled as: 1) BIOPSY TRAY-LF, Pack Number SPEC438
2024-09-04
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
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FDA Device Recall: Centurion procedure kits labeled as: 1) BONE MARROW TRAY, Pack Number SPEC025
2024-09-04
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
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FDA Device Recall: Medline procedure packs containing Shenli syringes, labeled as follows: 1) CV
2024-09-04
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
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FDA Device Recall: Centurion procedure packs, containing Caina syringes, labeled as: 1) BREAST
2024-09-04
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
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FDA Device Recall: Medline procedural kits labeled as: 1) MEDICAL CIRCUMCISION TRAY, Pack Number
2024-09-04
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
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FDA Device Recall: See RES Description
2024-09-04
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
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FDA Device Recall: Medline procedure packs containing Shenli syringes, labeled as follows: 1) ANGIO
2024-09-04
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
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FDA Device Recall: Medline procedural kits labeled as: 1) TYMPANOPLASTY , Pack Number CDS980203S
2024-09-04
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
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FDA Device Recall: Centurion procedure kits, labeled as: 1) 6" FEMORAL ARTERIAL LINE KIT- ICU, P
2024-09-04
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
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FDA Device Recall: Medline procedural kits labeled as: NEURO TRAY, Pack Number DYNJ55909B
2024-09-04
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
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FDA Device Recall: Medline procedural kits labeled as: 1) ALL DOC EYE PACK, Pack Number DYNJ51654
2024-09-04
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
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FDA Device Recall: Centurion procedure packs, containing Caina syringes, labeled as: 1) ARTHROG
2024-09-04
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
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FDA Device Recall: Medline procedural kits labeled as: 1) AFCH ANTERIOR SEGMENT PK, Pack Number
2024-09-04
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
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FDA Device Recall: Centurion procedure kits labeled as: 1) BIOPSY KIT, Pack Number DYNDA1466A;
2024-09-04
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
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FDA Device Recall: Medline procedural kits labeled as: 1) CIRCUMCISION TRAY, Pack Number CIT6715;
2024-09-04
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
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FDA Device Recall: Medline procedural kits labeled as: 1) CIRCUMCISION TRAY, Pack Number CIT6715
2024-09-04
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
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FDA Device Recall: See RES description
2024-09-04
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
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FDA Device Recall: Medline procedural kits labeled as: 1) DRAWER 3 LAB DRAW & IV START, Pack Num
2024-09-04
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
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FDA Device Recall: Medline procedural kits labeled as: 1) CAROTID ENDARTERECTOMY PK, Pack Number
2024-09-04
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
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FDA Device Recall: Medline procedure packs containing Shenli syringes, labeled as follows: 1) LO
2024-09-04
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
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FDA Device Recall: See RES description
2024-09-04
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
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FDA Device Recall: Medline procedure packs containing Shenli syringes, labeled as follows: 1) CV
2024-09-04
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
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FDA Device Recall: Medline procedural kits labeled as: 1) BIOPSY PACK, Pack Number DYNJ63370A;
2024-09-04
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
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FDA Device Recall: Medline procedural kits labeled as: 1) FETAL SURGERY-LF, Pack Number CDS84021
2024-09-04
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
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FDA Device Recall: Centurion procedure packs, containing Caina syringes, labeled as: SHAVE KIT,
2024-09-04
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
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FDA Device Recall: LINER, SOFT, SUCTION CANISTER, 1500CC, REF DYNDSCL1500
2024-08-28
Class II — A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
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FDA Device Recall: Medline medical procedure kits labeled as follows: a) HEART ANESTHESIA SET UP
2024-08-28
Class II — A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
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FDA Device Recall: LINER, SOFT, SUCTION CANISTER, 1500CC, REF OR929K
2024-08-28
Class II — A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
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FDA Device Recall: Medline medical procedure kits labeled as follows: a) CYSTO, REF DYNJ905000D;
2024-08-28
Class II — A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
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FDA Device Recall: Medline medical procedure kits labeled as follows: a) BASIC NASAL, REF DYNJ
2024-08-28
Class II — A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
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FDA Device Recall: 1,5L MED-SOFT SINGLE LINER WITH SOLIDIFIER, REF OR1920PG
2024-08-28
Class II — A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
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FDA Device Recall: Medline medical procedure kits labeled as follows: a) AAA CDS, REF CDS984011C
2024-08-28
Class II — A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
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FDA Device Recall: Medline medical procedure kits labeled as follows: a) TURNOVER KIT, REF DYKC1
2024-08-28
Class II — A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
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FDA Device Recall: 1,5L MED-SOFT LINER W/ 6MMX1,8M TUB. & ADULT VC, REF OR53926
2024-08-28
Class II — A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
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FDA Device Recall: Medline medical procedure kits labeled as follows: a) KIT CANISTER SUCT W 12F
2024-08-28
Class II — A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
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FDA Device Recall: Medline medical procedure kits labeled as follows: DENTAL, REF DYNJ909211A
2024-08-28
Class II — A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
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FDA Device Recall: Medline procedure kits labeled as: 1) NEPHROLOGY PACK, Pack Number DYNJ59089;
2024-08-14
Class I — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a r...
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FDA Device Recall: Centurion procedure kits labeled as: 1) CVC INSERT BUNDLE 16CM, Pack Number E
2024-08-14
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
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FDA Device Recall: Centurion procedure kits labeled as NEURO ANGIO PACK, Pack Number DYNDA1431A
2024-08-14
Class II — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a ...
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FDA Device Recall: Medline procedure kits labeled as: 1) WMC HYBRID OR PACK PART 1 , Pack Number
2024-08-14
Class I — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a r...
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FDA Device Recall: Sterile convenience kits: a. Medline Retrograde PK-22025203-LF, Pack #DYNJ47
2024-07-10
Class II — Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails.
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FDA Device Recall: Non-sterile convenience kits: a. Medline Difficult Airway Tray W/O Cook, Pac
2024-07-10
Class II — Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails.
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FDA Device Recall: Sterile surgical convenience kit: Medline Neuro IR Pack, Pack #DYNJ56073C, co
2024-07-10
Class II — Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails.
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FDA Device Recall: Non-sterile convenience kits: a. Medline CC Drawer 4 IV Circulation, Pack #AC
2024-07-10
Class II — Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails.
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FDA Device Recall: Non-sterile convenience kits: Medline Open Heart CDS, Pack #CDS981759C, conta
2024-07-10
Class II — Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails.
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FDA Device Recall: Sterile surgical convenience kits: a. Medline Cath Lab Special Procedure, Pa
2024-07-10
Class II — Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails.
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FDA Device Recall: MEDLINE LUER SLIP DISPOSABLE SYRINGE WITHOUT NEEDLE, REF SYR101020
2024-06-12
Class II — It has been identified that testing documentation does not support that the syringes can successfully deliver accurate volumes across the full range of their claimed graduated capacity and ...
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FDA Device Recall: MEDLINE LUER LOCK DISPOSABLE SYRINGE WITHOUT NEEDLE, REF SYR101010
2024-06-12
Class II — It has been identified that testing documentation does not support that the syringes can successfully deliver accurate volumes across the full range of their claimed graduated capacity and ...
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FDA Device Recall: Medline Sub-G Endotracheal Tube with Subglottic Suctioning: (1) REF DYNJ18860
2024-06-05
Class I — Complaints have been received that the device inflation tube detached and/or tore from the main tube, resulting in potential moisture buildup, loss of pressure, or inability to inflate. The...
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FDA Device Recall: Medline medical procedure kits, labeled as follows: a) PARACERVICAL PUD TRAY,
2024-06-05
Class II — Trumpet Needle Guide ring can detach when excessive pressure is applied.
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FDA Device Recall: Centurion OB INSTRUMENT TRAY, REF MN3925; Medical procedure convenience tray
2024-06-05
Class II — Trumpet Needle Guide ring can detach when excessive pressure is applied.
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FDA Device Recall: Namic FLUID DELIVERY SET, REF 91300040
2024-05-22
Class II — Products have a lack of sterility assurance.
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FDA Device Recall: namic CONVENIENCE KIT, a) CAROTID MANIFOLD KIT, REF 60011045; b) 3V MANIFOLD
2024-05-22
Class II — Products have a lack of sterility assurance.
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FDA Device Recall: Centurion manual surgical kits labeled as: a) STERILE 4-1/2" S/S SCISSOR (SS50
2024-04-10
Class II — Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
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FDA Device Recall: Centurion DISP.UMBILICAL CORD CLAMP CUTTER(CTR300), Product Code 67335
2024-04-10
Class II — Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
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FDA Device Recall: Centurion STERILE COTTON DENTAL ROLLS 6/PK, Product Code 9125ST6
2024-04-10
Class II — Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
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FDA Device Recall: Centurion Hemostat kits labeled as: a) STERILE CURV KELLY HEMOSTAT, Product Co
2024-04-10
Class II — Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
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FDA Device Recall: MEDLINE SWABSTICKS PVP 3 PK, Product Code DYNDA2724
2024-04-10
Class II — Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
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FDA Device Recall: MEDLINE M1S0179 STRL TAPE/PEN PACK, Product Code P519582A
2024-04-10
Class II — Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
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FDA Device Recall: Centurion STERILE #16 RUBBER BAND, Product Code EB16
2024-04-10
Class II — Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
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FDA Device Recall: Centurion retractor kits labeled as: a) STERILE 6-1/2" SENN RETRACTOR (ST7185),
2024-04-10
Class II — Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
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FDA Device Recall: Centurion Clamp kits labeled as: a) STERILE BACKHAUS TOWEL CLAMP (BTC173), Pro
2024-04-10
Class II — Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
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FDA Device Recall: MEDLINE SWABSTICKS ALCOHOL 3PK, Product code DYNDA2723
2024-04-10
Class II — Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
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FDA Device Recall: Centurion manual surgical kits labeled as: a) STERILE ALLIS TISS FCP 10", Prod
2024-04-10
Class II — Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
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FDA Device Recall: Centurion hook kits labeled as: a) STERILE SKIN HOOK FINE (EA3975F), Product Co
2024-04-10
Class II — Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
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FDA Device Recall: Centurion STERILE #5 LARYNGEAL MIRROR(505709), Product Code 67830
2024-04-10
Class II — Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
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FDA Device Recall: MEDLINE TRAY TRACH BASIC SOLUTION, REF DYND40511
2024-03-06
Class I — Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for...
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FDA Device Recall: Medline Kits, trays, and packs labeled as follows: C-SECTION, REF DYNJ904653G
2024-03-06
Class I — Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for...
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FDA Device Recall: Medline Kits, trays, and packs labeled as follows: a) ER LACERATION TRAY - SN
2024-03-06
Class I — Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for...
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FDA Device Recall: Centurion Kits, trays, and packs labeled as follows: a) IV SECUREMENT KIT, RE
2024-03-06
Class I — Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for...
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FDA Device Recall: Medline Kits, trays, and packs labeled as follows: a) GYN LAPAROSCOPY, REF CD
2024-03-06
Class I — Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for...
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FDA Device Recall: MEDLINE Kits, trays, and packs labeled as follows: a) ASC GENERAL MINOR CDS,
2024-03-06
Class I — Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for...
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FDA Device Recall: Medline Kits, trays, and packs labeled as follows: a) L&B CDS-LF, REF CDS9802
2024-03-06
Class I — Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for...
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FDA Device Recall: Medline Kits, trays, and packs labeled as follows: a) C L PREP, REF DYNJ69664
2024-03-06
Class I — Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for...
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FDA Device Recall: Medline Kits, trays, and packs labeled as follows: a) PORT REMOVAL PACK, REF
2024-03-06
Class I — Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for...
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FDA Device Recall: MEDLINE Kits, trays, and packs labeled as follows: CATHETERIZATION KIT, REF D
2024-03-06
Class I — Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for...
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FDA Device Recall: MEDLINE Kits, trays, and packs labeled as follows: a) DIALYSIS FISTULA KIT, R
2024-03-06
Class I — Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for...
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FDA Device Recall: Medline Kits, trays, and packs labeled as follows: a) TRACH CARE KIT, REF DYN
2024-03-06
Class I — Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for...
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FDA Device Recall: Medline Kits, trays, and packs labeled as follows: a) CENTRAL LINE TRAY, REF
2024-03-06
Class I — Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for...
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FDA Device Recall: MEDLINE Kits, trays, and packs labeled as follows: a) ASC MINOR THYROID CDS,
2024-03-06
Class I — Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for...
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FDA Device Recall: Medline Kits, trays, and packs labeled as follows: TRAY,L&D INSTRUMENT, REF D
2024-03-06
Class I — Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for...
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FDA Device Recall: MEDLINE Kits, trays, and packs labeled as follows: a) ARTERIAL LINE PACK, REF
2024-03-06
Class I — Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for...
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FDA Device Recall: Centurion Kits, trays, and packs labeled as follows: MAINTENANCE FLUSH KIT/BL
2024-03-06
Class I — Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for...
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FDA Device Recall: MEDLINE Kits, trays, and packs labeled as follows: a) ENDO KIT, REF DYKE1350
2024-03-06
Class I — Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for...
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FDA Device Recall: Medline Kits, trays, and packs labeled as follows: a) BLOOD DRAW KIT, REF DYN
2024-03-06
Class I — Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for...
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FDA Device Recall: Medline Kits, trays, and packs labeled as follows: a) CATARACT PACK, REF VAL0
2024-03-06
Class I — Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for...
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FDA Device Recall: Medline Kits, trays, and packs labeled as follows: a) 709E RECOVERY PACK A,B,
2024-03-06
Class I — Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for...
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FDA Device Recall: MEDLINE Kits, trays, and packs labeled as follows: a) C-SECTION, REF DYNJ9046
2024-03-06
Class I — Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for...
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FDA Device Recall: Medline Kits, trays, and packs labeled as follows: a) LACERATION KIT, REF SUT
2024-03-06
Class I — Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for...
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FDA Device Recall: Medline Kits, trays, and packs labeled as follows: a) KIT,SUCTION CATH,10FR W
2024-03-06
Class I — Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for...
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FDA Device Recall: Centurion Kits, trays, and packs labeled as follows: CIRCUMCISION TRAY, REF D
2024-03-06
Class I — Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for...
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FDA Device Recall: MEDLINE TRAY care and cleaning kits and trays for Tracheostomy and Stomas, label
2024-03-06
Class I — Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for...
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FDA Device Recall: MEDLINE Kits, trays, and packs labeled as follows: SERUM TEAR KIT, REF DYNDA154
2024-03-06
Class I — Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for...
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FDA Device Recall: Medline Kits, trays, and packs labeled as follows: CHP WOUND IRRIGATION KIT,
2024-03-06
Class I — Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for...
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FDA Device Recall: Medline Kits, trays, and packs labeled as follows: a) NUR 105, REF EDUC05053B
2024-03-06
Class I — Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for...
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FDA Device Recall: Centurion Kits, trays, and packs labeled as follows: EYE PREP KIT, REF ET1010
2024-03-06
Class I — Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for...
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FDA Device Recall: These wipes are saturated with 0.65% bleach solution. These wipes are antimicrob
2024-02-28
Class II — There is stability concern for products dated with a 24-month shelf life. Product is safe and effective up to 12 months shelf life.
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FDA Drug Recall: Medline Remedy Clinical TREAT Antifungal Cream, 2% Miconazole Nitrate, Paraben F
2024-02-14
Class II — Labeling: Not Elsewhere Classified; Product labeling contains the claim of 'Paraben Free' while the product does in fact contain parabens as part of the formulation/ ingredient list.
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FDA Device Recall: MEDLINE BLOOD CULTURE KIT, Reorder Number DYNDH1723
2024-02-07
Class II — Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood and Blood Culture Kits. This recall is due to kits built using a Bactec component lot and e...
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FDA Device Recall: MEDLINE BLOOD CULTURE KIT, Reorder Number DYNDH1622C
2024-02-07
Class II — Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood and Blood Culture Kits. This recall is due to kits built using a Bactec component lot and e...
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FDA Device Recall: MEDLINE BLOOD CULTURE COLLECTION KIT, Reorder Number DYNDH1714A
2024-02-07
Class II — Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood and Blood Culture Kits. This recall is due to kits built using a Bactec component lot and e...
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FDA Device Recall: MEDLINE BLOOD CULTURE BOTTLE KIT, Reorder Number DYNDH1738A
2024-02-07
Class II — Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood and Blood Culture Kits. This recall is due to kits built using a Bactec component lot and e...
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FDA Device Recall: MEDLINE ADULT BLOOD CULTURE KIT, Reorder Number DYNDH1694A
2024-02-07
Class II — Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood and Blood Culture Kits. This recall is due to kits built using a Bactec component lot and e...
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FDA Device Recall: Medline Gown Poly W/Breath Sleeves XL AAMIK Level 4 (Eclipse gown), REF SPT-2208
2024-01-17
Class II — Surgical gowns were manufactured with the wrong sleeve.
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FDA Device Recall: Tracheostomy care kits: (1) Medline Tracheostomy Clean and Care Tray with 14
2024-01-03
Class I — The component tracheostomy brush has a sharp edge at the tip that can potentially puncture tubing during use and/or cause user injury. Additionally, there have been incidents of the tracheo...
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FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20231220
The product description on the labeling includes the word "Sterile" or STRL", however the contents of the solution inside the foil sachet is non-steri | Product: STERILE PVP SOLUTION, REF DYNDA1907
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FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20231220
Undeclared latex | Product: Medline Leg bag, REF URO12573
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FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20231220
The product description on the labeling includes the word "Sterile" or STRL", however the contents of the solution inside the foil sachet is non-steri | Product: STERILE POVIDONE, REF DYNDA2061
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FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20231220
Undeclared latex | Product: Medline Leg bag, REF DYND12574
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FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20230927
4.5" Iris Scissors, Sterile, Curved (DYNJ04049) are being recalled due to the potential of the tip protector to fall off. The sharp tip of the scissor | Product: MEDLINE STERILE IRIS SCISSORS CVD/STD,...
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FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20230809
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. | Product: Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Ge...
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FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20230809
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. | Product: Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Ge...
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FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20230809
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. | Product: Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Ge...
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FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20230809
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. | Product: Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Ge...
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FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20230726
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. | Product: Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the followin...
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FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20230726
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. | Product: Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the followin...
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FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20230726
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. | Product: Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the followin...
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FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20230726
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. | Product: Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the followin...
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FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20230726
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. | Product: Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the followin...
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FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20230726
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. | Product: Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the followin...
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FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20230719
Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON-STERILE PVP SOLUTION, STERILE PACKAGING". | Product: MEDLINE NON-STERILE PVP SOLUTION, packaged in kit...
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FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20230719
Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON-STERILE PVP SOLUTION, STERILE PACKAGING". | Product: MEDLINE NON-STERILE PVP SOLUTION, packaged in kit...
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FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20230607
The kits were damaged by water. | Product: Procedure packs: (1) Medline Sterile Arthroscopy Pack, REF: DYNJ64242B; (2) Medline Sterile Shou
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FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20230222
The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapp | Product: Surgical convenience kits labeled as: ...
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FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20230222
The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapp | Product: Surgical convenience kits labeled as: ...
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FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20230222
The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapp | Product: Surgical convenience kits labeled as: ...
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FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20230215
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. | Product: Sterile Procedural Trays, labeled as the following: a. BRE...
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FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20230215
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. | Product: UNIVERSAL CORE DR RUNNELS PACK. Sterile Procedural Tray
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FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20230215
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. | Product: Sterile Procedural Trays, labeled as the following: AMBULATOR...
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FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20230215
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. | Product: Sterile Procedural Trays, labeled as the following: a. EAR CD...
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FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20230215
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. | Product: Sterile Procedural Trays, labeled as the following: a. C-...
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FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20230215
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. | Product: Sterile Procedural Trays, labeled as the following: a. EP LAB...
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FDA Device Recall: STERILE PVP SOLUTION, REF DYNDA1907
2023-12-20
Class II — The product description on the labeling includes the word "Sterile" or STRL", however the contents of the solution inside the foil sachet is non-sterile.
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FDA Device Recall: STERILE POVIDONE, REF DYNDA2061
2023-12-20
Class II — The product description on the labeling includes the word "Sterile" or STRL", however the contents of the solution inside the foil sachet is non-sterile.
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FDA Device Recall: Medline Leg bag, REF DYND12574
2023-12-20
Class II — Undeclared latex
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FDA Device Recall: STERILE BETADINE, REF DYNDA1998
2023-12-20
Class II — The product description on the labeling includes the word "Sterile" or STRL", however the contents of the solution inside the foil sachet is non-sterile.
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FDA Device Recall: Medline Leg bag, REF DYND12578
2023-12-20
Class II — Undeclared latex
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FDA Device Recall: STERILE PVP, REF DYNDA1649
2023-12-20
Class II — The product description on the labeling includes the word "Sterile" or STRL", however the contents of the solution inside the foil sachet is non-sterile.
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FDA Device Recall: STERILE STERILE PREP STICK, REF DYNDA1134
2023-12-20
Class II — The product description on the labeling includes the word "Sterile" or STRL", however the contents of the solution inside the foil sachet is non-sterile.
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FDA Device Recall: ADLT BLOOD CULTURE COLLECT KIT, REF DYNDH1245
2023-11-22
Class II — This recall is being issued due to items within the kit have expired prior to the overall kit expiration date listed on the insert.
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FDA Device Recall: PERIPHERAL BLOOD CULTURE DRAW, REF DYNDH1561
2023-11-22
Class II — This recall is being issued due to items within the kit have expired prior to the overall kit expiration date listed on the insert.
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FDA Device Recall: BLOOD CULTURE KIT, REF DYNDH1647B
2023-11-22
Class II — This recall is being issued due to items within the kit have expired prior to the overall kit expiration date listed on the insert.
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FDA Drug Recall: Clinical TREAT Antifungal Powder, Vanilla Scent, 3 OZ (85 g) tube, Active Ingred
2023-11-15
Class II — CGMP deviations: the product was shipped from the Manufacturer to a Medline warehouse and released to stock while it was still under investigation for low assay results on the active ingred...
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FDA Device Recall: MEDLINE ReNewal Harmonic ACE+7 Shears w/ Adv. Hemostasis Use Only w/ GEN11 SW v
2023-10-25
Class II — Various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on the packaging tray.
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FDA Device Recall: MEDLINE ReNewal Ligasure Maryland Jaw Sealer/Divider Nano-Coated Complatible wi
2023-10-25
Class II — Various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on the packaging tray.
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FDA Device Recall: Centurion Sterile CirClamp with 1.45cm Bell Reprocessed, Reorder CR3145K, 1 per
2023-10-11
Class II — The kits incorrectly contain CirClamp subassembly 345CRSAK which results in the kits containing an incorrect bell and base size.
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FDA Device Recall: MEDLINE STERILE IRIS SCISSORS CVD/STD, REF DYNJ04049
2023-09-27
Class II — 4.5" Iris Scissors, Sterile, Curved (DYNJ04049) are being recalled due to the potential of the tip protector to fall off. The sharp tip of the scissors could compromise the sterile barrier ...
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FDA Device Recall: HUDSON RCI Addipak, UNIT DOSE VIALS, 5mL Sterile 0.9% NaCl Solution for Inhalati
2023-09-20
Class I — Product dispositioned for scrap for sterility failure investigation that was inadvertently shipped to customers.
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FDA Device Recall: Total Hip Kit, REF DYNJ903275S; surgical convenience kit
2023-08-16
Class II — The prep solution included in the Total Hip Kit expires prior to the expiration date of the Kit.
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FDA Device Recall: Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel
2023-08-09
Class II — Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
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FDA Device Recall: Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel
2023-08-09
Class II — Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
View Source
FDA Device Recall: Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel
2023-08-09
Class II — Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
View Source
FDA Device Recall: Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel
2023-08-09
Class II — Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
View Source
FDA Device Recall: Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel
2023-08-09
Class II — Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
View Source
FDA Device Recall: Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel
2023-08-09
Class II — Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
View Source
FDA Device Recall: Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel
2023-08-09
Class II — Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
View Source
FDA Device Recall: Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel
2023-08-09
Class II — Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
View Source
FDA Device Recall: Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel
2023-08-09
Class II — Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
View Source
FDA Device Recall: Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel
2023-08-09
Class II — Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
View Source
FDA Device Recall: Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel
2023-08-09
Class II — Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
View Source
FDA Device Recall: Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel
2023-08-09
Class II — Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
View Source
FDA Device Recall: Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel
2023-08-09
Class II — Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
View Source
FDA Device Recall: Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel
2023-08-09
Class II — Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
View Source
FDA Device Recall: Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel
2023-08-09
Class II — Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
View Source
FDA Device Recall: Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel
2023-08-09
Class II — Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
View Source
FDA Device Recall: Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel
2023-08-09
Class II — Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
View Source
FDA Device Recall: Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel
2023-08-09
Class II — Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
View Source
FDA Device Recall: Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel
2023-08-09
Class II — Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
View Source
FDA Device Recall: Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel
2023-08-09
Class II — Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
View Source
FDA Device Recall: Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel
2023-08-09
Class II — Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
View Source
FDA Device Recall: Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel
2023-08-09
Class II — Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
View Source
FDA Device Recall: Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel
2023-08-09
Class II — Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
View Source
FDA Device Recall: Medline Probe Cover Kits containing Turkuaz Ultrasound Gel, Labeled as the follo
2023-08-09
Class II — Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
View Source
FDA Device Recall: Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel
2023-08-09
Class II — Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
View Source
FDA Device Recall: Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel
2023-08-09
Class II — Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
View Source
FDA Device Recall: Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel
2023-08-09
Class II — Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
View Source
FDA Device Recall: Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel
2023-08-09
Class II — Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
View Source
FDA Device Recall: Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel
2023-08-09
Class II — Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
View Source
FDA Device Recall: Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel
2023-08-09
Class II — Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
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FDA Device Recall: DYND3000xxP Series - Flexible Laryngeal Mask Airway Packs
2023-08-02
Class II — The case and each (i.e. packet) labels for the DYND3000xxP series do not include an expiration date, however, the lubricating jelly (MDS032280) included in the DYNDP3000xxP series is labele...
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FDA Device Recall: Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the follo
2023-07-26
Class II — Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
View Source
FDA Device Recall: Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the follo
2023-07-26
Class II — Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
View Source
FDA Device Recall: Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the follo
2023-07-26
Class II — Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
View Source
FDA Device Recall: Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the follo
2023-07-26
Class II — Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
View Source
FDA Device Recall: Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the follo
2023-07-26
Class II — Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
View Source
FDA Device Recall: Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the follo
2023-07-26
Class II — Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
View Source
FDA Device Recall: Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the follo
2023-07-26
Class II — Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
View Source
FDA Device Recall: Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the follo
2023-07-26
Class II — Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
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FDA Device Recall: Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the follo
2023-07-26
Class II — Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
View Source
FDA Device Recall: Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the follo
2023-07-26
Class II — Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
View Source
FDA Device Recall: Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the follo
2023-07-26
Class II — Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
View Source
FDA Device Recall: Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the follo
2023-07-26
Class II — Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
View Source
FDA Device Recall: Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the follo
2023-07-26
Class II — Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
View Source
FDA Device Recall: Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the follo
2023-07-26
Class II — Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
View Source
FDA Device Recall: Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the follo
2023-07-26
Class II — Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
View Source
FDA Device Recall: Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the follo
2023-07-26
Class II — Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
View Source
FDA Device Recall: Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the follo
2023-07-26
Class II — Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
View Source
FDA Device Recall: Medline O.R. Scissors, S/B, Sterile, 5.5, Model #DYND04000
2023-07-26
Class II — The scissors were manufactured without a tip protector resulting in the scissors breaking through the semi-rigid plastic tray compromising sterility.
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FDA Device Recall: Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the follo
2023-07-26
Class II — Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
View Source
FDA Device Recall: Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the follo
2023-07-26
Class II — Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
View Source
FDA Device Recall: Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the follo
2023-07-26
Class II — Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
View Source
FDA Device Recall: Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the follo
2023-07-26
Class II — Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
View Source
FDA Device Recall: Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the follo
2023-07-26
Class II — Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
View Source
FDA Device Recall: Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the follo
2023-07-26
Class II — Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
View Source
FDA Device Recall: Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the follo
2023-07-26
Class II — Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
View Source
FDA Device Recall: Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the follo
2023-07-26
Class II — Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
View Source
FDA Device Recall: Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the follo
2023-07-26
Class II — Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
View Source
FDA Device Recall: Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the follo
2023-07-26
Class II — Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
View Source
FDA Device Recall: Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the follo
2023-07-26
Class II — Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
View Source
FDA Device Recall: Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the follo
2023-07-26
Class II — Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
View Source
FDA Device Recall: Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the follo
2023-07-26
Class II — Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
View Source
FDA Device Recall: Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the follo
2023-07-26
Class II — Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
View Source
FDA Device Recall: Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the follo
2023-07-26
Class II — Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
View Source
FDA Device Recall: MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: OISC HAND BEAR,
2023-07-19
Class II — Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON-STERILE PVP SOLUTION, STERILE PACKAGING".
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FDA Device Recall: MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: TOTAL KNEE THEDA
2023-07-19
Class II — Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON-STERILE PVP SOLUTION, STERILE PACKAGING".
View Source
FDA Device Recall: MEDLINE NON-STERILE PVP SOLUTION, STERILE PACKAGING REF DYNDA2232A
2023-07-19
Class II — Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON-STERILE PVP SOLUTION, STERILE PACKAGING".
View Source
FDA Device Recall: MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: EAR CDS, Model N
2023-07-19
Class II — Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON-STERILE PVP SOLUTION, STERILE PACKAGING".
View Source
FDA Device Recall: MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: HYSTERO PACK, Mo
2023-07-19
Class II — Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON-STERILE PVP SOLUTION, STERILE PACKAGING".
View Source
FDA Device Recall: MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: a) TOTAL JOINT,
2023-07-19
Class II — Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON-STERILE PVP SOLUTION, STERILE PACKAGING".
View Source
FDA Device Recall: MEDLINE THERAHONEY GEL, 100% LEPTOSPERMUM SCOPARIUM HONEY, a) REF MNK0005, b) RE
2023-06-28
Class II — Medline issued a recall on TheraHoney Wound Gel due to the manufacturer notifying Medline of a sterilization dose audit failure on the wound gel and not augmenting the dose after failure pe...
View Source
FDA Device Recall: Procedure packs: (1) Medline Sterile Arthroscopy Pack, REF: DYNJ64242B; (2)
2023-06-07
Class II — The kits were damaged by water.
View Source
FDA Device Recall: Centurion CirClamp with 1.3cm Bell & Insert Reprocessed, Reorder #CR230K, Steril
2023-04-26
Class II — The CirClamp subassembly found in the kit was the incorrect size.
View Source
FDA Device Recall: (1) Medline Sterile Hand Pack, Item DYNJ63380A, 3 kits per case, contains BD Chl
2023-03-01
Class II — The convenience trays had improper placement of some of the components that were in the nonsterile portion of the tray, thus, not receiving sterilization.
View Source
FDA Device Recall: Medline Sterile Oncology Port Access Tray, Item #DYNDC2239, 20 sterile kits per
2023-03-01
Class II — The convenience trays had improper placement of some of the components that were in the nonsterile portion of the tray, thus, not receiving sterilization.
View Source
FDA Device Recall: (1) Medline Sterile Maximum Barrier Pack-LF, Item DYNJ0248546C, 6 kits per case,
2023-03-01
Class II — The convenience trays had improper placement of some of the components that were in the nonsterile portion of the tray, thus, not receiving sterilization.
View Source
FDA Device Recall: Surgical convenience kits labeled as: MEDLINE ARM/MINOR DRAPE CSTM, Reorder Nu
2023-02-22
Class II — The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.
View Source
FDA Device Recall: Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS L & D TRAY, Re
2023-02-22
Class II — The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.
View Source
FDA Device Recall: Surgical convenience kits labeled as: MEDLINE BREAST BIOPSY KIT, Reorder Number
2023-02-22
Class II — The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.
View Source
FDA Device Recall: Surgical convenience kits labeled as: MEDLINE PERF. ASSOC. CUT DOWN TRAY, Reord
2023-02-22
Class II — The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.
View Source
FDA Device Recall: Surgical convenience kits labeled as: MEDLINE PREP TRAY, Reorder Number DYNDL1
2023-02-22
Class II — The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.
View Source
FDA Device Recall: Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS NEONATAL PICC
2023-02-22
Class II — The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.
View Source
FDA Device Recall: Surgical convenience kits labeled as: MEDLINE CABG PACK, Reorder Number DYNDA28
2023-02-22
Class II — The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.
View Source
FDA Device Recall: Surgical convenience kits labeled as: MEDLINE PAIN TRAY, Reorder Number DYNJRA1
2023-02-22
Class II — The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.
View Source
FDA Device Recall: Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION
2023-02-15
Class II — Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
View Source
FDA Device Recall: UNIVERSAL CORE DR RUNNELS PACK. Sterile Procedural Tray
2023-02-15
Class II — Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
View Source
FDA Device Recall: Sterile Procedural Trays, labeled as the following: AMBULATORY MINI PACK
2023-02-15
Class II — Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
View Source
FDA Device Recall: Sterile Procedural Trays, labeled as the following: a. EAR CDS-LF b. SINUS CDS-
2023-02-15
Class II — Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
View Source
FDA Device Recall: Sterile Procedural Trays, labeled as the following: a. C-SECTION OR 30 CDS
2023-02-15
Class II — Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
View Source
FDA Device Recall: Sterile Procedural Trays, labeled as the following: a. EP LAB PACEMAKER PACK b.
2023-02-15
Class II — Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
View Source
FDA Device Recall: Sterile Procedural Trays, labeled as the following: a. CELEBRATION ROBOTIC
2023-02-15
Class II — Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
View Source
FDA Device Recall: Sterile Procedural Trays, labeled as the following: a. LAPAROTOMY CDS-LF b. LAP
2023-02-15
Class II — Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
View Source
FDA Device Recall: LOCAL PACK. Sterile Procedural Tray.
2023-02-15
Class II — Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
View Source
FDA Device Recall: Sterile Procedural Trays, labeled as the following: a. RHINOPLASTY PACK b. O
2023-02-15
Class II — Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
View Source
FDA Device Recall: FEMORAL ARTERY PACK-LF. Sterile Procedural Tray
2023-02-15
Class II — Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
View Source
FDA Device Recall: Sterile Procedural Trays, labeled as the following: a. BASIC EYE PACK-LF b
2023-02-15
Class II — Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
View Source
FDA Device Recall: Sterile Procedural Trays, labeled as the following: a. UNIVERSAL PLASTIC b.
2023-02-15
Class II — Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
View Source
FDA Device Recall: Sterile Procedural Trays, labeled as the following: a. MAJOR CDS-LF b. BURN
2023-02-15
Class II — Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
View Source
FDA Device Recall: Sterile Procedural Trays, labeled as the following: MINOR BASIC PACK-LF
2023-02-15
Class II — Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
View Source
FDA Device Recall: Sterile Procedural Trays, labeled as the following: a. ORAL SURGERY PACK-LF
2023-02-15
Class II — Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
View Source
FDA Device Recall: Sterile Procedural Trays, labeled as the following: a. GYN ABD CDS b. LAVH
2023-02-15
Class II — Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
View Source
FDA Device Recall: Sterile Procedural Trays, labeled as the following: a. WOUND CLOSURE TRAY b
2023-02-15
Class II — Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
View Source
FDA Device Recall: Sterile Procedural Trays, labeled as the following: GENERAL ENDOSCOPY
2023-02-15
Class II — Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
View Source
FDA Device Recall: Sterile Procedural Trays, labeled as the following: a. CARDIAC CATH PACK-LF;
2023-02-15
Class II — Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
View Source
FDA Device Recall: Sterile Procedural Tray, labeled as the following: a. PAIN SERVICE PACK-LF;
2023-02-15
Class II — Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
View Source
FDA Device Recall: Sterile Procedural Trays, labeled as the following: a. GYN LAPAROTOMY HARPE
2023-02-15
Class II — Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
View Source
FDA Device Recall: Sterile Procedural Trays, labeled as the following: a. BASIN SET-UP PACK b. LA
2023-02-15
Class II — Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
View Source
FDA Device Recall: Sterile Procedural Trays, labeled as the following: LS MS PACK
2023-02-15
Class II — Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
View Source
FDA Device Recall: Sterile Procedural Trays, labeled as the following: DR MOTT DRAPE PACK
2023-02-15
Class II — Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
View Source
FDA Device Recall: TRACH PACK. Sterile Procedural Tray.
2023-02-15
Class II — Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
View Source
FDA Device Recall: Sterile Procedural Trays, labeled as the following: a. GYN-URO LAPSCP CDS-L
2023-02-15
Class II — Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
View Source
FDA Device Recall: ANCILLARY PACK-LF. Sterile Procedural Tray.
2023-02-15
Class II — Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
View Source
FDA Device Recall: Non-sterile procedural trays labeled as MAJOR/MINOR, 3 per case
2023-02-08
Class II — Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the outer foil layer causing a breach in the sterile packaging.
View Source
FDA Device Recall: Non-sterile procedural trays labeled as ORTHO TRAUMA, 1 per case
2023-02-08
Class II — Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the outer foil layer causing a breach in the sterile packaging.
View Source
FDA Device Recall: MEDLINE UNITE FOOT & ANKLE DRILL BIT, 1.3MM Solid Core, REF MPN10013
2023-02-08
Class II — The recall is due to observed intra-operative screw failure. When pre-drilled with ¿1.3mm drill bit for ¿2.0mm screws and ¿1.6mm drill bit for ¿2.4mm we have observed screw failure due to e...
View Source
FDA Device Recall: Non-sterile procedural trays labeled as CRANI, 2 per case
2023-02-08
Class II — Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the outer foil layer causing a breach in the sterile packaging.
View Source
FDA Device Recall: Non-sterile procedural trays labeled as TOTAL KNEE KIT, 1 per case
2023-02-08
Class II — Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the outer foil layer causing a breach in the sterile packaging.
View Source
FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20221109
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal. | Product: CENTURION MEDICAL PRODUCTS NICU PICC INSERTION BUNDLE W/O, REF CVI44...
View Source
FDA Recall: MEDLINE INDUSTRIES, LP - Northfield — Class II
20221102
Adult Blood Culture Collect kit and Pre-Op Changing Bathing Kit contain an incorrect expiration date on a component with the kit. CHG Solution with th | Product: MEDLINE ADLT BLOOD CLUTURE COLLECT KIT...
View Source
FDA Device Recall: CENTURION MEDICAL PRODUCTS NICU PICC INSERTION BUNDLE W/O, REF CVI4470. Conveni
2022-11-09
Class II — Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
View Source
FDA Device Recall: MEDLINE DENTAL PACK, REF DYNJ66983. Convenience kit used in medical procedures.
2022-11-09
Class II — Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
View Source
FDA Device Recall: MEDLINE CVC BARRIER KIT, REF DYNJ80485. Convenience kit used in medical procedu
2022-11-09
Class II — Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
View Source
FDA Device Recall: MEDLINE RADIOLOGY PROCEDURE PACK, REF DYNJ67150A. Convenience kit used in medic
2022-11-09
Class II — Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
View Source
FDA Device Recall: BAUSCH + LOMB BASIC OPHTHALMIC PACK, REF LYN023BSBLB. Convenience kit used in s
2022-11-09
Class II — Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
View Source
FDA Device Recall: BAUSCH + LOMB CATARACT TRAY, REF LYN023FACTB. Convenience kit used in surgical
2022-11-09
Class II — Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
View Source
FDA Device Recall: MEDLINE LITHOTOMY, REF DYNJ50099C. Convenience kit used in medical/surgical pro
2022-11-09
Class II — Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
View Source
FDA Device Recall: BAUSCH + LOMB PHACO PACK, REF LYN011PHNHD. Convenience kit used in surgical pro
2022-11-09
Class II — Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
View Source
FDA Device Recall: MEDLINE ADLT BLOOD CLUTURE COLLECT KIT, Reorder #: DYNDH1245
2022-11-02
Class II — Adult Blood Culture Collect kit and Pre-Op Changing Bathing Kit contain an incorrect expiration date on a component with the kit. CHG Solution with the Pre-Op Changing Bathing Kit and Bacte...
View Source
FDA Device Recall: CENTURION SnagFree Chest Tube insertion Tray, Reorder CHT545
2022-10-26
Class II — One lot of chest tube insertion trays, containing a silk suture component that is restricted to 1 cycle of sterilization, was processed though 2 cycles.
View Source
FDA Device Recall: VENCLOSE, VENCLOSE PROCEDURE PACK, 7VM, REF VC-PPH-67A. Cardiovascular procedu
2022-10-19
Class II — Impacted Venclose Procedure Packs contain a 12cm introducer/sheath component, either component #128626 - SET INTRO 7FX12CM FITS 0.018 or component #137339 - SET INTRO 6.5FX12CM FITS 0.018, ...
View Source
FDA Device Recall: MEDLINE CLEARPRO TRACH T-PIECE CLOSED SUCTION CATHETER, flat peel pouch EA, 10 E
2022-10-05
Class II — Potential for the suction catheter to come apart from the green connector near the thumb valve. The connector is coming apart from the assembled device when pulling the catheter out of the ...
View Source
FDA Device Recall: MEDLINE Polyurethane Foam Bedside Cleaning Kit, REF DYK500FS
2022-06-08
Class II — Sporadic reports were received of discoloration on the foam sponge on certain lots of the product, which has been identified as microbial contamination.
View Source
FDA Device Recall: MEDLINE Polyurethane Bedside Cleaning Kit, REF DYK500FSAW
2022-06-08
Class II — Sporadic reports were received of discoloration on the foam sponge on certain lots of the product, which has been identified as microbial contamination.
View Source
FDA Device Recall: Medline Standard PVC Laryngeal Masks, 1 device per pouch, 5 each pouches per box
2022-04-20
Class II — The mask cuff may disconnect from the device's breathing tube.
View Source
FDA Device Recall: Stanbio TDM/Beta-Hydroxybutyrate Linearity Standards, packaged in boxes containi
2022-04-20
Class II — The product was stored incorrectly due to improper storage controls which may lead to delayed results.
View Source
FDA Device Recall: MEDLINE Micro-Kill Bleach Germicidal Bleach Wipes
2022-03-09
Class II — Micro-Kill Bleach Wipes contain out of specification (low) levels of Sodium Hypochlorite.
View Source
FDA Device Recall: HARDY DIAGNOSTICS CatScreen, 25dsk/vial
2022-02-09
Class II — Product stored incorrectly in temperature controlled setting instead of refrigeration.
View Source
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