MEDLINE INDUSTRIES INC — Federal Records | CFVA

FDA Recall: Medline Industries, LP — Class I 20260520

Medline has identified the presence of particulate within the fluid path of the Manifolds. | Product: Medline medical convenience kits, containing Namic Manifold, Labeled as: HEART CATH PACK-LF, Medl...

View Source

FDA Recall: Medline Industries, LP — Class II 20260513

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the vali | Product: See RES for complete list. Medline Con...

View Source

FDA Recall: Medline Industries, LP — Class II 20260513

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the vali | Product: Medline Convenience Kits: 1) WMC I D ...

View Source

FDA Recall: Medline Industries, LP — Class II 20260513

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the vali | Product: Medline Convenience Kits: 1) PPE KIT,...

View Source

FDA Recall: Medline Industries, LP — Class II 20260513

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the vali | Product: Medline Convenience Kits: 1) LITHOTOM...

View Source

FDA Recall: Medline Industries, LP — Class II 20260513

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the vali | Product: See RES for complete list. Medline Con...

View Source

FDA Recall: Medline Industries, LP — Class II 20260513

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the vali | Product: Medline Convenience Kits: 1) BASIC NE...

View Source

FDA Recall: Medline Industries, LP — Class II 20260513

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the vali | Product: Medline Convenience Kits: 1) SCC RF P...

View Source

FDA Recall: Medline Industries, LP — Class II 20260513

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the vali | Product: Medline Convenience Kits: 1) DYNDA300...

View Source

FDA Recall: Medline Industries, LP — Class II 20260506

During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that | Product: Medline Neuro Sponges, various dimensi...

View Source

FDA Recall: Medline Industries, LP — Class II 20260506

During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that | Product: Medline medical procedure kits, contai...

View Source

FDA Recall: Medline Industries, LP — Class II 20260506

Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. | Product: Medline medical convenience kits, cont...

View Source

FDA Recall: Medline Industries, LP — Class II 20260506

During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that | Product: Medline medical procedure kits, contai...

View Source

FDA Recall: Medline Industries, LP — Class II 20260506

During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that | Product: Medline medical procedure kits, contai...

View Source

FDA Recall: Medline Industries, LP — Class II 20260506

During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that | Product: Medline medical procedure kits, contai...

View Source

FDA Recall: Medline Industries, LP — Class II 20260506

Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. | Product: Medline and Centurion medical convenie...

View Source

FDA Recall: Medline Industries, LP — Class II 20260506

During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that | Product: Medline medical procedure kits, contai...

View Source

FDA Recall: Medline Industries, LP — Class II 20260506

Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. | Product: Medline and Centurion medical convenie...

View Source

FDA Recall: Medline Industries, LP — Class II 20260429

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. | Product: Medline Kits: 1) HEART TRANSPLANT BIOPSY, Model Number: DYNJ3754...

View Source

FDA Recall: Medline Industries, LP — Class II 20260429

Unapproved design changes to the products outside of the 510(k) clearance. | Product: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes GU DAVINCI

View Source

FDA Recall: Medline Industries, LP — Class II 20260429

Unapproved design changes to the products outside of the 510(k) clearance. | Product: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes TAVR PACK

View Source

FDA Recall: Medline Industries, LP — Class II 20260429

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. | Product: Medline Namic Guidewires: 1) GUIDEWIRE 3MMJ 0.035X260CM LT, Mode...

View Source

FDA Recall: Medline Industries, LP — Class II 20260429

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. | Product: Medline Kits: 1) CATH LAB CDS, Model Number: CDS840228F; 2) IR P...

View Source

FDA Recall: Medline Industries, LP — Class II 20260429

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. | Product: Medline Kits: 1) ANGIOGRAPHY PACK-LF, Model Number: DYNJQ0505M; ...

View Source

FDA Recall: Medline Industries, LP — Class II 20260429

Unapproved design changes to the products outside of the 510(k) clearance. | Product: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ANGIO KIT

View Source

FDA Recall: Medline Industries, LP — Class II 20260429

Unapproved design changes to the products outside of the 510(k) clearance. | Product: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes Medline Co

View Source

FDA Recall: Medline Industries, LP — Class I 20260415

Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which ma | Product: Medline medical convenience kits, cont...

View Source

FDA Recall: Medline Industries, LP — Class I 20260415

Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which ma | Product: NAMIC Angiographic Control Syringe, la...

View Source

FDA Recall: Medline Industries, LP — Class I 20260415

Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which ma | Product: Medline medical convenience kits, cont...

View Source

FDA Recall: Medline Industries, LP — Class I 20260415

Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which ma | Product: Medline medical convenience kits, cont...

View Source

FDA Recall: Medline Industries, LP — Class I 20260415

Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which ma | Product: Medline medical convenience kits, cont...

View Source

FDA Recall: Medline Industries, LP — Class II 20260408

Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit | Product: THORACIC ROBOTS, DYNJ908777B

View Source

FDA Recall: Medline Industries, LP — Class II 20260304

Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tea | Product: Medline Kits containing Tego Connector...

View Source

FDA Recall: Medline Industries, LP — Class II 20260304

Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tea | Product: Convenience kits containing Tego Conne...

View Source

FDA Recall: Medline Industries, LP — Class II 20260225

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the vali | Product: Medline Convenience Kits: 1) KIT SURG...

View Source

FDA Recall: Medline Industries, LP — Class II 20260225

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the vali | Product: Medline Convenience Kits: 1) KIT TRIP...

View Source

FDA Recall: Medline Industries, LP — Class II 20260225

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the vali | Product: Medline Convenience Kits: 1) KIT ACES...

View Source

FDA Recall: Medline Industries, LP — Class II 20260225

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the vali | Product: Medline Convenience Kits: 1) DRAPE PA...

View Source

FDA Recall: Medline Industries, LP — Class II 20260225

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the vali | Product: Medline Convenience Kits: 1) LVAD DRI...

View Source

FDA Recall: Medline Industries, LP — Class II 20260218

Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined | Product: Medline medical convenience kits packa...

View Source

FDA Recall: Medline Industries, LP — Class I 20260218

These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory re | Product: Reprocessed Abbott Inquiry Steerable D...

View Source

FDA Recall: Medline Industries, LP — Class II 20260204

Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing crack | Product: Medline medical procedure convenience ...

View Source

FDA Recall: Medline Industries, LP — Class II 20260204

Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing crack | Product: Medline medical procedure convenience ...

View Source

FDA Recall: Medline Industries, LP — Class II 20260121

Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the hand | Product: Medline medical procedure convenience ...

View Source

FDA Recall: Medline Industries, LP — Class II 20260121

Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the | Product: Medline Kits containing B. Braun IV Ad...

View Source

FDA Device Recall: THORACIC ROBOTS, DYNJ908777B 2026-04-08

Class II — Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single use biopsy valves. Potential...

View Source

FDA Device Recall: Airway Exam Kit, DYKE1796 2026-04-08

Class II — Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single use biopsy valves. Potential...

View Source

FDA Device Recall: Medline Kits containing ENFIT G-TUBE CONNECTOR 1. SKU DYKM2720 G/J TUBE CARE 2026-04-08

Class II — Connectors were not manufactured to required dimensional specifications and may not form a proper seal with ENFit-style devices, which could lead to leakage. Leakage may result in delayed c...

View Source

FDA Device Recall: Medline kits containing Olympus biopsy valves: 1. BRONCHOSCOPY, DYNJ900898I D 2026-04-08

Class II — Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single use biopsy valves. Potential...

View Source

FDA Device Recall: ENFIT G-TUBE CONNECTOR, MEDLINE Item No. ENFIT1010GC 2026-04-08

Class II — Connectors were not manufactured to required dimensional specifications and may not form a proper seal with ENFit-style devices, which could lead to leakage. Leakage may result in delayed c...

View Source

FDA Device Recall: Medline kits containing Olympus biopsy valves: 1. BRONCH PROCEDURE KIT, DYKE2 2026-04-08

Class II — Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single use biopsy valves. Potential...

View Source

FDA Device Recall: Medline Kits containing Cardinal Health s Aqua-Seal Chest Drainage Unit: 1) OPE 2026-03-18

Class II — The instructions for use (IFUs) on specified Cardinal Health Chest Drainage Units (CDUs) and accessories have been updated to clarify the intended target patient population as adults, 18 ye...

View Source

FDA Device Recall: Medline Kits containing Tego Connectors Medline DIALYSIS ON/OFF KIT SKU EBSI17 2026-03-04

Class II — Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occ...

View Source

FDA Device Recall: Convenience kits containing Tego Connectors Medline DIALYSIS DRSNG CHNG SKU 2026-03-04

Class II — Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occ...

View Source

FDA Device Recall: Convenience kits used for dialysis maintenance Medline ADD A CATH DIALYSIS KI 2026-03-04

Class II — Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occ...

View Source

FDA Device Recall: Medline Convenience Kits: 1) NAIL KIT, Model Number: DYKM1528 2026-03-04

Class II — Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile ...

View Source

FDA Device Recall: Medline Kits containing Tego Connectors: Medline IR Pack, SKU DYNJ67205C Medli 2026-03-04

Class II — Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occ...

View Source

FDA Device Recall: Convenience kits containing Tego Connectors: Medline DIALYSIS DRESSING CHANGE 2026-03-04

Class II — Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occ...

View Source

FDA Device Recall: Meijer STERILE saline wound wash, First Aid Cleansing Spray, 0.9% USP SODIUM CHL 2026-03-04

Class II — Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile ...

View Source

FDA Device Recall: Medline Convenience Kits: 1) KIT SURG ONC EXCISION BREAST, Model Number: DYKMBN 2026-02-25

Class II — Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycle...

View Source

FDA Device Recall: Medline Convenience Kits: 1) KIT TRIPLE LUMEN INSERTION, Model Number: DYNDM103 2026-02-25

Class II — Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycle...

View Source

FDA Device Recall: Medline Convenience Kits: 1) KIT ACES INSERT PEG, Model Number: DYKMBNDL130; 2026-02-25

Class II — Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycle...

View Source

FDA Device Recall: Medline Convenience Kits: 1) DRAPE PACK-CHOICE, Model Number: DYNJ63118A 2026-02-25

Class II — Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycle...

View Source

FDA Device Recall: Medline Convenience Kits: 1) LVAD DRIVELINE TRAY, Model Number: DM1035; 2) KI 2026-02-25

Class II — Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycle...

View Source

FDA Device Recall: Medline Convenience Kits: 1) ADMIT KIT, Model Number: DYKA1343A 2026-02-25

Class II — Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycle...

View Source

FDA Device Recall: Medline Industries IV Administration and Extension Sets: 1) DBD-IV ADMIN SET,60 2026-02-25

Class II — Under circumstances involving exposure to particular chemicals and mechanical forces, the male luer connectors for the specified IV Administration and Extension sets may leak, crack, and/or...

View Source

FDA Device Recall: Medline Convenience Kits: 1) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS98 2026-02-25

Class II — Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycle...

View Source

FDA Device Recall: Medline Convenience Kits: 1) MAJOR LAPAROTOMY CDS, Model Number: CDS860015U; 2026-02-25

Class II — Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycle...

View Source

FDA Device Recall: Medline Convenience Kits: 1) KIT GENERAL CLOSURE, Model Number: DYKMBNDL200A 2026-02-25

Class II — Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycle...

View Source

FDA Device Recall: Medline Convenience Kits: 1) KIT STC TRACHEOSTOMY, Model Number: DYKMBNDL55; 2026-02-25

Class II — Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycle...

View Source

FDA Device Recall: Medline Convenience Kits: 1) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS9830 2026-02-25

Class II — Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycle...

View Source

FDA Device Recall: Medline Convenience Kits: 1) LITHOTOMY PACK, Model Number: DYNJ83185; 2) LITH 2026-02-25

Class II — Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycle...

View Source

FDA Device Recall: Medline Convenience Kits: 1) PPE KIT, Model Number: DYK1011945P 2026-02-25

Class II — Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycle...

View Source

FDA Device Recall: Medline Convenience Kits: 1) LVAD DRIVELINE TRAY, Model Number: DM1035A; 2) L 2026-02-25

Class II — Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycle...

View Source

FDA Device Recall: Medline Convenience Kits: 1) ANCILLARY PACK-LF, Model Number: DYNJ0185290G; 2 2026-02-25

Class II — Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycle...

View Source

FDA Device Recall: Medline Convenience Kits: 1) WMC I D PACK-LF, Model Number: DYNJ50806L 2026-02-25

Class II — Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycle...

View Source

FDA Device Recall: Medline Convenience Kits: 1) ROBOTIC GYN CDS-1, Model Number: CDS982893I; 2) 2026-02-25

Class II — Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycle...

View Source

FDA Device Recall: Medline Convenience Kits: 1) BURN PACK, Model Number: DYNJ15668R; 2) BURN PAC 2026-02-25

Class II — Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycle...

View Source

FDA Device Recall: Medline Convenience Kits: 1) BAPTIST FLOYD ENDO GI KIT, Model Number: DYKE1455B 2026-02-25

Class II — Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycle...

View Source

FDA Device Recall: Medline Convenience Kits: 1) PLASTIC BIN W/MISC KITS, Model Number: ACC010499; 2026-02-25

Class II — Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycle...

View Source

FDA Device Recall: Medline Convenience Kits: 1) NEURO SHUNT- CODMAN, Model Number: CDS860018G; 2 2026-02-25

Class II — Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycle...

View Source

FDA Device Recall: Medline Convenience Kits: 1) ENDO KIT W/SYRINGE, Model Number: DYKE1743; 2) B 2026-02-25

Class II — Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycle...

View Source

FDA Device Recall: Medline Surgical Gowns: 1) GOWN,NONRNF,L,30/CS, Model Number: DYNJP2001; 2) G 2026-02-25

Class II — Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycle...

View Source

FDA Device Recall: Medline Convenience Kits: 1) OB KIT, Model Number: DYKM2326; 2) KIT LABOR DEL 2026-02-25

Class II — Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycle...

View Source

FDA Device Recall: Medline Convenience Kits: 1) TOTE ABRAMS KNEE ARTHROSCOPY, Model Number: DYKM18 2026-02-25

Class II — Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycle...

View Source

FDA Device Recall: Medline Surgical Packs: 1) PACK,UNIVERSAL,ULTRAGARD,5/CS, Model Number: DYNJP10 2026-02-25

Class II — Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycle...

View Source

FDA Device Recall: Medline Convenience Kits: 1) PICC LINE TRAY, Model Number: 00-401993O; 2) COD 2026-02-25

Class II — Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycle...

View Source

FDA Device Recall: Medline Convenience Kits: 1) DENTAL PACK, Model Number: DYNDA3003 2026-02-25

Class II — Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycle...

View Source

FDA Device Recall: Medline Convenience Kits: 1) KIT OPHTHALMIC RUPTURE GLOBE, Model Number: DYKMBN 2026-02-25

Class II — Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycle...

View Source

FDA Device Recall: Medline medical convenience kits packaged as: 1) POWERGLIDE DRESSING CHANGE K 2026-02-18

Class II — Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packagi...

View Source

FDA Device Recall: Reprocessed Abbott Inquiry Steerable Diagnostic Catheters: Abbott Inquiry S 2026-02-18

Class I — These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granuloma...

View Source

FDA Device Recall: Medline 14 Fr Suction Catheter Kits SKU DYND40972 - respiratory convenience kit 2026-02-18

Class II — A smaller open suction catheter, the 8 Fr Suction Catheter, may have been packed within the kit instead of the required 14 Fr Suction Catheter. Use of the smaller size catheter may result i...

View Source

FDA Device Recall: Medline ReNewal Reprocessed Webster CS Catheters: Webster CS Catheter 10 Elec 2026-02-18

Class I — These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granuloma...

View Source

FDA Device Recall: Reprocessed Siemens ACUSON AcuNav Diagnostic Ultrasound Catheters: ACUSON Acu 2026-02-18

Class I — These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granuloma...

View Source

FDA Device Recall: Medline medical convenience kits packaged as: PEDIATRIC CATH SECUREMENT DRSG, K 2026-02-18

Class II — Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packagi...

View Source

FDA Device Recall: Reprocessed St. Jude Supreme and Response Diagnostic Electrophysiology Catheters 2026-02-18

Class I — These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granuloma...

View Source

FDA Device Recall: Medline medical procedure convenience kits labeled as: 1) WATKINS SPINE PACK- 2026-02-04

Class II — Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MAS...

View Source

FDA Device Recall: Medline medical procedure convenience kits labeled as: NERVE BLOCK TRAY 2, Kit 2026-02-04

Class II — Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MAS...

View Source

FDA Device Recall: Medline medical procedure convenience kits labeled as: 1) BREAST-HERNIA-PORT 2026-02-04

Class II — Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MAS...

View Source

FDA Device Recall: Medline medical procedure convenience kits labeled as: 1) SMJ LAP CHOLE PACK- 2026-02-04

Class II — Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MAS...

View Source

FDA Device Recall: Medline medical procedure convenience kits labeled as: 1) INPATIENT CTRL LN D 2026-02-04

Class II — Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MAS...

View Source

FDA Device Recall: Medline medical procedure convenience kits labeled as: HEAD SHAVE-LATEX SAFE KI 2026-02-04

Class II — Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MAS...

View Source

FDA Device Recall: Medline medical procedure convenience kits labeled as: 1) DRAWER 1 AIRWAY, Ki 2026-02-04

Class II — Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MAS...

View Source

FDA Device Recall: Medline medical procedure convenience kits labeled as: 1) C-SECTION PACK, Kit 2026-02-04

Class II — Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MAS...

View Source

FDA Device Recall: Medline medical procedure convenience kits labeled as: 1) CATH LAB PACEMAKER 2026-02-04

Class II — Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MAS...

View Source

FDA Device Recall: Medline medical procedure convenience kits labeled as: 1) DEPAUL BASIC NEURO- 2026-02-04

Class II — Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MAS...

View Source

FDA Device Recall: Medline medical procedure convenience kits labeled as: 1) RR-GYN LAPAROSCOPY 2026-02-04

Class II — Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MAS...

View Source

FDA Device Recall: MEDLINE beds labeled as: Full Electric Lightweight Homecare Bed, REF MDR107003L 2026-01-28

Class I — Medline Industries has identified a potential hazard involving the hand control pendant and associated wires. In rare and atypical scenarios such as operating the bed above its specified wei...

View Source

FDA Device Recall: MEDLINE beds labeled as: Full Electric Low Basic Homecare Bed, REF MDR107003ELO 2026-01-28

Class I — Medline Industries has identified a potential hazard involving the hand control pendant and associated wires. In rare and atypical scenarios such as operating the bed above its specified wei...

View Source

FDA Device Recall: MEDLINE beds labeled as: 1) Full Electric Basic Homecare Bed, REF MDR107003E; 2) 2026-01-28

Class I — Medline Industries has identified a potential hazard involving the hand control pendant and associated wires. In rare and atypical scenarios such as operating the bed above its specified wei...

View Source

FDA Device Recall: MEDLINE beds labeled as: Full Electric Low Lightweight Homecare Bed, REF MDR1070 2026-01-28

Class I — Medline Industries has identified a potential hazard involving the hand control pendant and associated wires. In rare and atypical scenarios such as operating the bed above its specified wei...

View Source

FDA Device Recall: MEDLINE beds labeled as: Semi Electric Lightweight Homecare Bed, REF MDR107002L 2026-01-28

Class I — Medline Industries has identified a potential hazard involving the hand control pendant and associated wires. In rare and atypical scenarios such as operating the bed above its specified wei...

View Source

FDA Device Recall: Medline medical procedure convenience kits labeled as: KIT ROBOTICS UROLOGY PRO 2026-01-21

Class II — Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of th...

View Source

FDA Device Recall: Medline Kits containing B. Braun IV Administration Sets and Pump Administration 2026-01-21

Class II — Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck...

View Source

FDA Device Recall: Medline Kits containing B. Braun IV Administration Sets and Pump Administration 2026-01-21

Class II — Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck...

View Source

FDA Device Recall: Medline medical procedure convenience kits labeled as: 1) LAVH PROCEDURE, REF 2026-01-21

Class II — Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of th...

View Source

FDA Device Recall: Medline Kits containing B. Braun IV Administration Sets and Pump Administration 2026-01-21

Class II — Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck...

View Source

FDA Device Recall: Medline Kits containing B. Braun IV Administration Sets and Pump Administration 2026-01-21

Class II — Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck...

View Source

FDA Device Recall: Medline Kits containing B. Braun IV Administration Sets and Pump Administration 2026-01-21

Class II — Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck...

View Source

FDA Device Recall: Medline medical procedure convenience kits labeled as: 1) LAPAROSCOPY CDS-LF, 2026-01-21

Class II — Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of th...

View Source

FDA Device Recall: Medline Kits containing B. Braun IV Administration Sets and Pump Administration 2026-01-21

Class II — Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck...

View Source

FDA Device Recall: Medline Hudson RCI Medium Concentration Oxygen Masks: 1041CE MASK,OXYGEN,UND 2026-01-14

Class II — Firm received multiple complaints regarding tubing disconnecting from oxygen mask. If issue occurs during use, may lead to delay in patient care and patient may experience shortness of brea...

View Source

FDA Recall: Medline Industries, LP — Class II 20251217

Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the | Product: Quick Strip Fabric Sterile Adhesive Ba...

View Source

FDA Recall: Medline Industries, LP — Class II 20251126

Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instru | Product: MEDLINE convenience kits labeled as: ...

View Source

FDA Recall: Medline Industries, LP — Class II 20251126

Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instru | Product: MEDLINE convenience kits labeled as: ...

View Source

FDA Recall: Medline Industries, LP — Class II 20251029

Medline has identified a limited quantity of saline IV flush syringes that may not meet the required concentration of sodium chloride. | Product: Excelsior Medical, 0.9% Sodium Chloride Injection, USP...

View Source

FDA Recall: Medline Industries, LP — Class I 20251008

Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual particulates | Product: Reprocessed Livewire Steerable Electro...

View Source

FDA Device Recall: Quick Strip Fabric Sterile Adhesive Bandages, 1" x 3", Medline Item Number NON25 2025-12-17

Class II — Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the sterility of the product.

View Source

FDA Device Recall: Quick Strip Fabric Sterile Adhesive Bandages, 0.75" x 3", Medline Item Number NO 2025-12-17

Class II — Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the sterility of the product.

View Source

FDA Device Recall: Quick Strip Plastic Sterile Adhesive Bandages, 0.75" x 3", Medline Item Number N 2025-12-17

Class II — Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the sterility of the product.

View Source

FDA Device Recall: Fur Friends Plastic Sterile Adhesive Bandages, 0.75" x 3", Medline Item Number N 2025-12-17

Class II — Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the sterility of the product.

View Source

FDA Device Recall: CURAD Germ-Shield Touch-Free Fabric Bandages, Sterile, 0.75" x 3", 30/Box, Medli 2025-12-17

Class II — Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the sterility of the product.

View Source

FDA Device Recall: MEDLINE convenience kits labeled as: 1) ACH PLASTICS BREAST-LF, REF CDS983639 2025-11-26

Class II — Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their r...

View Source

FDA Device Recall: MEDLINE convenience kits labeled as: CIRCUMCISION PACK, REF DYNJ16826O 2025-11-26

Class II — Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their r...

View Source

FDA Device Recall: MEDLINE convenience kits labeled as: 1) MINOR EYE TRAY #81, REF DYNJ27466S; 2025-11-26

Class II — Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their r...

View Source

FDA Device Recall: MEDLINE convenience kits labeled as: 1) CENTRAL LINE PACK, REF DYNJ00281P; 2) F 2025-11-26

Class II — Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their r...

View Source

FDA Device Recall: MEDLINE convenience kits labeled as: GP-LEEP PACK-LF, REF PHS396969004F 2025-11-26

Class II — Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their r...

View Source

FDA Device Recall: MEDLINE convenience kits labeled as: 1) GYN LAPAROSCOPY CDS #34-RF, REF CDS92 2025-11-26

Class II — Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their r...

View Source

FDA Device Recall: MEDLINE convenience kits labeled as: 1) MAJOR VAGINAL HARPER PACK-LF, REF DYN 2025-11-26

Class II — Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their r...

View Source

FDA Device Recall: MEDLINE convenience kits labeled as: 1) C-SECTION OR 30 CDS, REF CDS820075W; 2025-11-26

Class II — Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their r...

View Source

FDA Device Recall: MEDLINE convenience kits labeled as: CATH LAB PACEMAKER PACK, REF DYNJ59818A 2025-11-26

Class II — Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their r...

View Source

FDA Device Recall: MEDLINE convenience kits labeled as LOCAL BASIC, REF DYNJ34418M 2025-11-26

Class II — Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their r...

View Source

FDA Device Recall: MEDLINE convenience kits labeled as: 1) MAJOR LAPAROTOMY CDS, REF CDS860015W; 2025-11-26

Class II — Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their r...

View Source

FDA Device Recall: Medline Renewal LigaSure Blunt Tip Sealer/Divider, Compatible with FT10 Generato 2025-11-19

Class II — Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged.

View Source

FDA Device Recall: Medline Renewal Ligasure Impact Sealer/Divider NanoCoated, Compatible with FT10 2025-11-19

Class II — Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged.

View Source

FDA Device Recall: Medline Renewal LigaSure Small Jaw Instrument (Purple/White), Compatible with FT 2025-11-19

Class II — Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged.

View Source

FDA Device Recall: Medline Renewal Ligasure Blunt Tip Sealer/Divider NanoCoated, Compatible with FT 2025-11-19

Class II — Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged.

View Source

FDA Device Recall: Medline Renewal Ligasure Maryland Jaw Sealer/Divider NanoCoated, Compatible with 2025-11-19

Class II — Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged.

View Source

FDA Device Recall: Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; 2025-11-19

Class I — Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate del...

View Source

FDA Device Recall: Medline Renewal Ligasure Blunt Tip Sealer/Divider NanoCoated, Compatible with FT 2025-11-19

Class II — Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged.

View Source

FDA Device Recall: Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; 2025-11-19

Class I — Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate del...

View Source

FDA Device Recall: DYNJ909119G ROBOTIC GASTRIC LAP SLEEVE-LF DYNJ909127F CYSTO DYNJ909129D GENERA 2025-11-19

Class I — Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate del...

View Source

FDA Device Recall: Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; 2025-11-19

Class I — Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate del...

View Source

FDA Device Recall: Convenience Kit, BREAST HERNIA DYNJ909125G 2025-11-19

Class I — Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate del...

View Source

FDA Device Recall: Medline RenewalLigasure Blunt Tip Sealer/Divider, NanoCoated Compatible with FT1 2025-11-19

Class II — Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged.

View Source

FDA Device Recall: Convenience kits; DYNJ901047R ORTHO SPINE FUMICH DYNJ902308K TOTAL JOINT DYNJ 2025-11-19

Class I — Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate del...

View Source

FDA Drug Recall: Medline, Alcohol Prep Pads (2-Ply Pad, 70% Isopropyl Alcohol), 100 eaches per bo 2025-10-29

Class II — Subpotent Drug

View Source

FDA Device Recall: Excelsior Medical, 0.9% Sodium Chloride Injection, USP - 10 mL Fill, Item Number 2025-10-29

Class II — Medline has identified a limited quantity of saline IV flush syringes that may not meet the required concentration of sodium chloride.

View Source

FDA Device Recall: Reprocessed Livewire Steerable Electrophysiology Catheter Item Numbers 401575 2025-10-08

Class I — Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual particulates on patient-contacting surfaces are used...

View Source

FDA Device Recall: Sterile Medline Convenience Kits: 1) EXTREMITY PACK, Model Number: DYNJ45701B 2025-10-08

Class I — Convenience kits labeled as sterile have not gone through the sterilization process.

View Source

FDA Device Recall: Reprocessed Webster CS Catheter 10 Electrodes for electrophysiological mapping o 2025-10-08

Class I — Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual particulates on patient-contacting surfaces are used...

View Source

FDA Device Recall: Medline Kits: 1) VALVE PACK-LF, Model Number: DYNJ0415366P; 2) VALVE PACK-LF, 2025-10-08

Class I — The kits contain certain lots of cannula products where the catheter may not retain its shape.

View Source

FDA Device Recall: Sterile Medline Convenience Kits: 1) MAJOR PACK L-F, Model Number: DYNJ0382730O 2025-10-08

Class I — Convenience kits labeled as sterile have not gone through the sterilization process.

View Source

FDA Device Recall: Reprocessed Inquiry Steerable Diagnostics Catheter for electrogram recording and 2025-10-08

Class I — Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual particulates on patient-contacting surfaces are used...

View Source

FDA Drug Recall: READYPREP PVP, Povidone-Iodine 10% Solution, Topical Antiseptic, Not Sterile, 1 2025-10-01

Class III — Subpotent drug

View Source

FDA Device Recall: Medline CHEST TUBE REORDER NO: DYNJ36762A 2022-09-14

Class II — Due to a non-sterile component (tape) being place within the sterile portion of the Chest Tube Convenience Kit

View Source

FDA Recall: Medline Industries Inc — Class II 20211222

NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020. | Product: EVLP Convenience Pack/Kit

View Source

FDA Recall: Medline Industries Inc — Class II 20211222

NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020. | Product: Venous Access Pack-LF Convenience Kit

View Source

FDA Recall: Medline Industries Inc — Class II 20210818

The kits may contain an expired component. | Product: Medline Arthroscopy Kit, convenience kit, REF DYNJ904304B, containing expired component NaCl 3000mL

View Source

FDA Recall: Medline Industries Inc — Class II 20210728

Potential for mold contamination (Aspergillus vadensis) | Product: Cotton Rounds/Pads under the following brand names: 1. BEAUTY 360 Extra Large Premium Cotton Ovals

View Source

FDA Recall: Medline Industries Inc — Class II 20210113

The cylindrical sponge component is not x-ray detectable. | Product: Resect. Intest. Laparo-LF, Model DYNJ42667A - Product Usage: This is a type of convenience kit used

View Source

FDA Drug Recall: Hand Sanitizer Foam (ethyl alcohol), 62% v/v, packaged in a) 1.5 Oz. cans, NDC 5 2021-12-29

Class II — Defective Container: Customer complaints for leaking bottles and dispensing issues.

View Source

FDA Device Recall: EVLP Convenience Pack/Kit 2021-12-22

Class II — NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020.

View Source

FDA Device Recall: Venous Access Pack-LF Convenience Kit 2021-12-22

Class II — NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020.

View Source

FDA Device Recall: Major Vascular CDS Convenience Kit 2021-12-22

Class II — NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020.

View Source

FDA Device Recall: Bedside PICC CDS Convenience Kit 2021-12-22

Class II — NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020.

View Source

FDA Device Recall: NAMIC Stopcocks: (1) NAMIC STOPCOCK, 200 psi (14 bar), REF 70015002, UPN H965 2021-10-06

Class II — Potential for sterile barrier breach. Microscopic pinholes within the sterile pouch could potentially lead to non-sterile conditions.

View Source

FDA Device Recall: Medline Arthroscopy Kit, convenience kit, REF DYNJ904304B, containing expired c 2021-08-18

Class II — The kits may contain an expired component.

View Source

FDA Device Recall: Medline Knee Arthroscopy Kit, convenience kit, REF DYNJ902838C, containing expi 2021-08-18

Class II — The kits may contain an expired component.

View Source

FDA Device Recall: Cotton Rounds/Pads under the following brand names: 1. BEAUTY 360 Extra Large 2021-07-28

Class II — Potential for mold contamination (Aspergillus vadensis)

View Source

FDA Drug Recall: READYPREP CHG, 2% Chlorhexidine Gluconate Cloth, 2 9x10.5 in (22.9x26.7 cm) Disp 2021-06-16

Class III — Superpotent Drug: Product is above specification for active ingredient, 2% Chlorhexidine Gluconate.

View Source

FDA Device Recall: Medline Tissue Recovery Instrument Set, Reorder #DYNJ64347A, packaged 3/case, St 2021-06-16

Class II — The devices may not meet the minimum required sterility assurance level.

View Source

FDA Device Recall: Diluent, Stat-Site B-HB, 6x 3ML - Product Usage: Intended to be used with the St 2021-04-21

Class II — Possible false negative or false positive results due to the product being compromised during shipment.

View Source

FDA Device Recall: RNA MEDICAL, QCHGB HEMOGLOBIN CONTROL, MULTI, REF QC HGB - Product Usage: monito 2021-03-24

Class II — Product was compromised during shipment.

View Source

FDA Device Recall: Resect. Intest. Laparo-LF, Model DYNJ42667A - Product Usage: This is a type of c 2021-01-13

Class II — The cylindrical sponge component is not x-ray detectable.

View Source

FDA Device Recall: Cardiac Pack - LF, Model DYNJ31903I - Product Usage: This is a type of convenien 2021-01-13

Class II — The cylindrical sponge component is not x-ray detectable.

View Source

FDA Recall: Medline Industries Inc — Class II 20201014

The buckle on the Gait Belt may break due to degradation of the material due to exposure to gamma radiation. | Product: Quick Release Gait Belt, 60

View Source

FDA Recall: Medline Industries Inc — Class II 20200527

Loose silicone particulate was found to be present on the shaft of the silicone catheters. | Product: SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 8 Fr 3 ml - Product Usage: Medline Silicone Fol...

View Source

FDA Recall: Medline Industries Inc — Class II 20200527

Loose silicone particulate was found to be present on the shaft of the silicone catheters. | Product: SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 6 Fr 1.5 ml - Product Usage: Medline Silicone F...

View Source

FDA Recall: Medline Industries Inc — Class II 20200304

The sterile pack inside the Complete Delivery System (CDS) did not go through a complete sterilization cycle, therefore the sterility of these compone | Product: Medline ROBOTIC-LF REF CDS984543B L...

View Source

FDA Device Recall: RevMedX Trauma Dressings are packaged in a Tyvek Peel pouch, 1 Trauma Dressing p 2020-12-23

Class II — RevMedX Trauma Dressing is being recalled due to package seal integrity.

View Source

FDA Device Recall: Quick Release Gait Belt, 60 2020-10-14

Class II — The buckle on the Gait Belt may break due to degradation of the material due to exposure to gamma radiation.

View Source

FDA Device Recall: Kit Model #650301018, MTO Vascular Surgery - Cleveland Clinic PG - Product Usage 2020-10-14

Class II — Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.

View Source

FDA Device Recall: Kit Model #65021652, MTO Left Heart Kit United Reg Health - Product Usage: NAMIC 2020-10-14

Class II — Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.

View Source

FDA Device Recall: Kit Model #650600111, MTO Left Heart St Francis Hosp - PG - Product Usage: NAMIC 2020-10-14

Class II — Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.

View Source

FDA Device Recall: Kit Model #65220955, MTO Left Heart Kit VA Med San Francisco - Product Usage: NA 2020-10-14

Class II — Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.

View Source

FDA Device Recall: Kit Model #650304917, MTO Protection Station Plus with Drape - Product Usage: NA 2020-10-14

Class II — Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.

View Source

FDA Device Recall: Kit Model #650301023, MTO Radiology Kit Cleveland Clinic - Product Usage: NAMIC 2020-10-14

Class II — Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.

View Source

FDA Device Recall: ClearPro Closed Suction Catheter, Model DYNCPDS14T, 14 Fr FOR ENDOTRACHEAL TUBE 2020-10-14

Class II — There have been reports of the suction catheter coming apart from the device assembly during use.

View Source

FDA Device Recall: Control, Calibrator Verified, Triage BNP, Model ALR88755 2020-10-07

Class II — Product was shipped with refrigeration (ice) instead of frozen (dry ice).

View Source

FDA Device Recall: Central Line Dressing Change Tray 2020-09-30

Class II — Potential of incomplete seals impacting the sterility of the kit.

View Source

FDA Device Recall: ClearPro Trach T-Piece Closed Suction Catheter, Model DYNCPTP14T, 14 Fr 12.5 IN 2020-08-05

Class II — There are reports of the suction catheter coming apart from the device assembly during use.

View Source

FDA Device Recall: SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 8 Fr 3 ml - Product Usage: Me 2020-05-27

Class II — Loose silicone particulate was found to be present on the shaft of the silicone catheters.

View Source

FDA Device Recall: SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 6 Fr 1.5 ml - Product Usage: 2020-05-27

Class II — Loose silicone particulate was found to be present on the shaft of the silicone catheters.

View Source

FDA Device Recall: Medline Stick Sponge Presaturated W/PVP REF DYND70288 DYND70288H 2/PK Expiration 2020-04-01

Class II — Voids were discovered in the packaging seal and loss of sterility on the outside of the contents within the Tyvek Form-Fill-Seal packaging.

View Source

FDA Device Recall: Medline ROBOTIC-LF REF CDS984543B Lot 20AKA927 Expiration 2020-09-30 GTIN ( 2020-03-04

Class II — The sterile pack inside the Complete Delivery System (CDS) did not go through a complete sterilization cycle, therefore the sterility of these components cannot be guaranteed.

View Source

FDA Device Recall: Medline DYNDA1928 VP TRAY WITH PVP Packaged in Mexico GLOVE:Made in Malaysia 2020-02-05

Class II — There is potential for the sterile wrap to become loose while in transit and compromise the sterile barrier.

View Source

FDA Device Recall: EVENCARE G3 Blood Glucose Test Strips, 1 test strip per foil pouch, 50 foil pouc 2019-12-04

Class II — Incomplete seal and premature expiration of individually packaged Blood Glucose Test Strips.

View Source

FDA Device Recall: Semi-Rigid Suction Canister, 3000cc. Model Numbers OR530 and OR530H. For OR530 2019-10-30

Class II — Potential for the Semi-Rigid canister lid to fragment during use.

View Source

FDA Device Recall: MEDLINE ELECTRIC SURGICAL CLIPPER AND BASE, REF DYND70800 Product Usage: Med 2019-10-02

Class II — The recall is being conducted due to a potential defective component on the circuit board causing the charger base to overheat which could result in a charger base malfunction.

View Source

FDA Device Recall: Medline SYRINGE, PISTON,IRR TRAY,W/.9, REF DYNC2303. Sterile Piston Irrigation 2019-09-04

Class II — Samples in the identified lot were found to have incomplete or open packaging seals.

View Source

FDA Device Recall: Centurion Convenience Kits, containing BD Alaris Pump Infusion Sets. BD code 115 2019-08-21

Class I — This recall is a sub recall to BD s recent Class I recall for the Alaris Pump Infusion Set due to an issue with the consistency of the inner lumen thickness of the silicone tubing segment wh...

View Source

FDA Device Recall: Medline Primary Warmer Pack, Product No. DYNJ52510A. The Medline Primary Warmer 2019-08-21

Class I — The Vyaire enFlow disposable cartridge was recalled due to the potential for unsafe aluminum levels to elute into the infusate. The Use of the BD Alaris Pump Infusion Set may lead to serious...

View Source

FDA Device Recall: Anti-fog solution packaged in a Tyvek peel pouch and it is placed into various k 2019-07-24

Class II — The Anti-Fog Solution may not defog properly due to a degradation in the chemical properties.

View Source

FDA Recall: MEDLINE INDUSTRIES INC — Class II 20181017

Firm received sporadic reports of discoloration on certain lots of the product, which has been identified as common mold. | Product: Unna-Z: Unna Boot Compression Wrap with Zinc Oxide and Calamine, It...

View Source

FDA Recall: Medline Industries Inc — Class II 20180606

The product packaging seal has the potential to experience seal creep. This may result in gaps to be created in the seals of the packaging and may imp | Product: MEDLINE Sterile* Needle Counter, 40Ct....

View Source

FDA Drug Recall: SparkleFresh Fluoride Toothpaste, Sodium Monofluorophosphate 0.76%, a) 17 g tube 2018-11-14

Class II — Microbial Contamination of Non-Sterile Product

View Source

FDA Device Recall: Unna-Z: Unna Boot Compression Wrap with Zinc Oxide and Calamine, Item Numbers: 2018-10-17

Class II — Firm received sporadic reports of discoloration on certain lots of the product, which has been identified as common mold.

View Source

FDA Device Recall: Art-Line Surgery Pack-LF, STERILE, 40 packs each per case. 2018-09-12

Class II — Multiple surgical packs were assembled with a non-sterile CHG disk labeled as BIOPATCH" (kit component #52655) attached to the outside of the sterile pack. This may pose potential risk of ...

View Source

FDA Device Recall: PICC Tray, STERILE, 12 packs each per case. 2018-09-12

Class II — Multiple surgical packs were assembled with a non-sterile CHG disk labeled as BIOPATCH" (kit component #52655) attached to the outside of the sterile pack. This may pose potential risk of ...

View Source

FDA Device Recall: Medline 0.9 % Sodium Chloride Injection, USP 5 mL in 10 mL Syringe ZR In 2018-09-05

Class II — Packaged with an incorrect overwrap.

View Source

FDA Device Recall: BARD MYPICC Kit, REF CK000095B, 5F French Size, packaged 5 kits/case, Sterile, R 2018-07-18

Class II — One of the cases of product might not have been sterilized.

View Source

FDA Device Recall: MEDLINE Sterile* Needle Counter, 40Ct. Foam Block / Adhesive, reorder: DYNJNC40A 2018-06-06

Class II — The product packaging seal has the potential to experience seal creep. This may result in gaps to be created in the seals of the packaging and may impact the sterility of the Needle Counter...

View Source

FDA Device Recall: MEDLINE O.R. Necessities(R) STERILE R, Needle Counter/Compte-aiguiles/Caja de ag 2018-06-06

Class II — The product packaging seal has the potential to experience seal creep. This may result in gaps to be created in the seals of the packaging and may impact the sterility of the Needle Counter...

View Source

FDA Device Recall: MEDLINE O.R. Necessities(TM) Sterile* Needle Counter, 100 Ct. Double Magnet / Fo 2018-06-06

Class II — The product packaging seal has the potential to experience seal creep. This may result in gaps to be created in the seals of the packaging and may impact the sterility of the Needle Counter...

View Source

FDA Device Recall: MEDLINE O.R. Necessities(TM) Sterile* Needle Counter, 40 Ct. Double Magnet / Foa 2018-06-06

Class II — The product packaging seal has the potential to experience seal creep. This may result in gaps to be created in the seals of the packaging and may impact the sterility of the Needle Counter...

View Source

FDA Drug Recall: PVP Scrub Solution, Povidone Iodine, 7.5% (equivalent to 0.75% available iodine) 2018-03-07

Class II — Subpotent Drug: product not meeting the iodine assay level requirements through the labeled expiry.

View Source

FDA Drug Recall: Medline Suture Removal Tray. Sterile. Single use only. Packaged in Mexico for 2018-02-07