co_sos
1 records
Department of Justice
1 records
DOJ: Covidien to Pay Over $17 Million to The United States for Allegedly Providing Illegal Remuneration in the Form of Practice and Market Development Supp
2019-03-11
Covidien LP has agreed to pay $17,477,947 to resolve allegations that it violated the False Claims Act by providing free or discounted practice development and market development support to physicians...
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EPA (Environmental Protection Agency)
1 records
fda
383 records
FDA Device Recall: HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Pro
2026-03-18
Class II — Due to complaints and investigations stating that alarms from the primary patient bedside monitor was not alarming/being transmitted and received on the remote patient monitoring system.
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FDA Device Recall: Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thi
2025-11-19
Class II — A manufacturing issue could lead to a malformed cover tube press which can lead to internal components' movement during firing - leading to the potential for uncontrolled motion.
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FDA Device Recall: Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thi
2025-11-19
Class II — A manufacturing issue could lead to a malformed cover tube press which can lead to internal components' movement during firing - leading to the potential for uncontrolled motion.
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FDA Device Recall: Newport HT70 Ventilator, REF: HT70M-JP-NA, HT70M-CN-NA, HT70M-ES-EU, HT70M-PT-BR
2025-06-18
Class I — Ventilator Printed Circuit Board Assembly may have two separate capacitors that may fail, which may result in the ventilator either shutting down during use, thus necessitating use of an alt...
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FDA Device Recall: Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cann
2025-04-02
Class I — Tracheostomy tube with cuff reusable inner cannula has a flange that may disconnect from the outer cannula of the device, which could cause respiratory failure, aspiration, unspecified tissu...
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FDA Recall: Covidien LP — Class II
20241106
Specific lots of the Chameleon PTA Balloon Catheter failed to meet in-house balloon pressure testing. | Product: Chameleon PTA Balloon Catheter with Injection Port 5mm x 40mm x 75cm (CFN CH05-40-75US)...
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FDA Recall: Covidien — Class I
20240828
Battery management system within Laryngoscope devices may deplete below the deign threshold which may result in thermal event followed by risk of expl | Product: McGrath Mac Video Laryngoscope, REF: 3...
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FDA Recall: Covidien — Class II
20240508
manufacturing defects to sensor cable connectors may result in error codes or non-functioning channel | Product: Medtronic Invos, Reusable Infant Sensor Adapter Cable for PM7100, REF: PMAC71RIC
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FDA Recall: Covidien, LP — Class II
20240410
The potential for trocar seal disengagement when using mesh products incorrectly with the device. | Product: Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BT
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FDA Recall: Covidien, LP — Class II
20240410
Under certain firing conditions, reloads were found to articulate in an uncontrolled manner potentially causing disruption to the staple line. The iss | Product: Signia" Small Diameter Curved Tip Inte...
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FDA Recall: Covidien LP — Class II
20240207
Specific lots of sutures were sterilized with gamma doses that exceeded the range approved. The extra gamma levels may decrease the strength of the su | Product: Surgilon Braided Nylon sutures: 888...
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FDA Device Recall: Chameleon PTA Balloon Catheter with Injection Port 5mm x 40mm x 75cm (CFN CH05-4
2024-11-06
Class II — Specific lots of the Chameleon PTA Balloon Catheter failed to meet in-house balloon pressure testing.
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FDA Device Recall: McGrath Mac Video Laryngoscope, REF: 300-000-000 , Non-Sterile, Rx Only
2024-08-28
Class I — Battery management system within Laryngoscope devices may deplete below the deign threshold which may result in thermal event followed by risk of explosion.
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FDA Device Recall: Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly
2024-08-28
Class II — IFU update to address device's battery handling information.
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FDA Device Recall: EsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx Only
2024-06-19
Class II — Due to saline conductivity issues, their is a potential that dilation catheters may provide inaccurate esophageal diameter measurements that may lead to various harms.
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FDA Device Recall: Medtronic Invos, Reusable Infant Sensor Adapter Cable for PM7100, REF: PMAC71RIC
2024-05-08
Class II — manufacturing defects to sensor cable connectors may result in error codes or non-functioning channel
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FDA Device Recall: Medtronic Invos, Reusable Sensor Cable for PM7100, REF: PMAC71RSC
2024-05-08
Class II — manufacturing defects to sensor cable connectors may result in error codes or non-functioning channel
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FDA Device Recall: Palindrome Precision HSI Chronic Catheter Sport Pack 14.5 Fr/Ch (4.8mm) x 19 c
2024-05-01
Class II — Products may not be heparin coated as indicated on the label-leads to a potential loss of benefit due to the absence of the heparin coating
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FDA Device Recall: Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BT
2024-04-10
Class II — The potential for trocar seal disengagement when using mesh products incorrectly with the device.
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FDA Device Recall: Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT
2024-04-10
Class II — Under certain firing conditions, reloads were found to articulate in an uncontrolled manner potentially causing disruption to the staple line. The issue is related to components in impacted...
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FDA Device Recall: Covidien Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTV
2024-04-10
Class II — Under certain firing conditions, reloads were found to articulate in an uncontrolled manner potentially causing disruption to the staple line. The issue is related to components in impacted...
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FDA Device Recall: Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BT
2024-04-10
Class II — The potential for trocar seal disengagement when using mesh products incorrectly with the device.
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FDA Device Recall: Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTSNL
2024-04-10
Class II — The potential for trocar seal disengagement when using mesh products incorrectly with the device.
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FDA Device Recall: Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BTNL
2024-04-10
Class II — The potential for trocar seal disengagement when using mesh products incorrectly with the device.
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FDA Device Recall: Situate Laparotomy Sponge, RF and X-ray Detectable, REF: L1818-04P01C-1
2024-03-27
Class II — Packs including 5 laparotomy sponges may contain incorrect product with a blue loop, X-ray detectable feature, and ethylene oxide treatment; however, this incorrect product wasn't steam pr...
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FDA Device Recall: AbsorbaTack Absorbable Fixation Device 30 Violet Absorbable Tacks 5 mm- -intend
2024-02-14
Class II — Packaging of the device may cause a low seal strength in the side seal of the foil pouch potentially resulting in a sterile/moisture barrier breach, compromising the product sterility
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FDA Device Recall: Surgilon Braided Nylon sutures: 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 8886
2024-02-07
Class II — Specific lots of sutures were sterilized with gamma doses that exceeded the range approved. The extra gamma levels may decrease the strength of the sutures over time, which could result in ...
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FDA Recall: Covidien LP — Class I
20230823
Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubric | Product: MAHURKAR 12 Fr High Pressure Triple Lu...
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FDA Recall: Covidien LP — Class I
20230823
Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubric | Product: MAHURKAR 12 Fr Triple Lumen Acute Dia...
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FDA Recall: Covidien LP — Class I
20230823
Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubric | Product: MAHURKAR 12 Fr High Pressure Triple Lu...
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FDA Recall: Covidien LP — Class I
20230823
Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubric | Product: MAHURKAR 12 Fr High Pressure Triple Lu...
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FDA Recall: Covidien LP — Class I
20230823
Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubric | Product: MAHURKAR 12 Fr High Pressure Triple Lu...
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FDA Recall: Covidien, LP — Class II
20230308
Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact | Product: Surgilon Braided Nylon suture Product D...
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FDA Recall: Covidien, LP — Class II
20230308
Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact | Product: Dermalon Monofilament Nylon Suture: (...
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FDA Recall: Covidien, LLC — Class II
20230118
The product is labeled with the incorrect expiration date. | Product: COVIDIEN Emprint Ablation Catheter with Thermosphere Technology, Bronchoscopic Ablation, REF CA108L1
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FDA Device Recall: McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000, Sterile EO, Rx O
2023-11-08
Class II — Laryngoscope blades may contain an ineffective application of anti-fog agent which may result in condensation accumulating causing the screen to be blurred or obscured.
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FDA Device Recall: Puritan Bennett Cuff Pressure Manager, REF: 180-03
2023-10-11
Class II — Inadequate internal fixation of the power inlet port to the cuff pressure manager device causes the external power inlet to became dislodged within the device housing after several uses, wh...
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FDA Device Recall: Palindrome Chronic Catheter Kit Symmetrical Tip14.5 Fr/Ch(4.8mm)x23cm
2023-10-04
Class II — Some catheter kits labeled as 23 cm implant length incorrectly included catheters of 28 cm implant length; the actual catheter implant length is identifiable based upon the correct labeling...
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FDA Device Recall: MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straig
2023-08-23
Class I — Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occ...
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FDA Device Recall: MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions,
2023-08-23
Class I — Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occ...
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FDA Device Recall: MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Curved
2023-08-23
Class I — Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occ...
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FDA Device Recall: MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved
2023-08-23
Class I — Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occ...
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FDA Device Recall: MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Straig
2023-08-23
Class I — Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occ...
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FDA Device Recall: MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, K
2023-08-23
Class I — Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occ...
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FDA Device Recall: MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Straig
2023-08-23
Class I — Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occ...
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FDA Device Recall: MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, K
2023-08-23
Class I — Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occ...
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FDA Device Recall: MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Straig
2023-08-23
Class I — Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occ...
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FDA Device Recall: MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved
2023-08-23
Class I — Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occ...
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FDA Device Recall: MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions,
2023-08-23
Class I — Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occ...
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FDA Device Recall: MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions,
2023-08-23
Class I — Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occ...
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FDA Device Recall: MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved
2023-08-23
Class I — Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occ...
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FDA Device Recall: MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved
2023-08-23
Class I — Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occ...
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FDA Device Recall: MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straig
2023-08-23
Class I — Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occ...
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FDA Device Recall: MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Curved
2023-08-23
Class I — Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occ...
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FDA Device Recall: MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions, K
2023-08-23
Class I — Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occ...
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FDA Device Recall: MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Curved
2023-08-23
Class I — Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occ...
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FDA Device Recall: Covidien Cytosponge Cell Collection Device, REF: CYTO-201; and Covidien Cytospon
2023-08-09
Class II — Cell Collection Device may be at increased risk of the sponge detaching from the string during removal of the device from the patient, which could lead to device fragments in patient, obstr...
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FDA Device Recall: VersaOne Reusable Positioning Cannula 11mm Standard, Model Number RC11STS
2023-05-03
Class II — There is a manufacturing non-conformance that may result in a metal shaving (burr) on the inside of the VersaOneTM Reusable Positioning Cannula, located where the Cannula and Body component...
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FDA Device Recall: Step Bladeless Trocars, 10 mm cannula and dilator with radially expandable sleev
2023-04-19
Class II — Medtronic was made aware of a supplier calibration issue during the contract sterilization process that may lead to unsterile product. Use of affected product may lead to an unspecified inf...
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FDA Device Recall: Chromic Gut Absorbable Sutures, SURGIGUT* 0 CHR GS-25 90CM X36 (CG-904), SURGIGU
2023-04-19
Class II — Medtronic was made aware of a supplier calibration issue during the contract sterilization process that may lead to unsterile product. Use of affected product may lead to an unspecified inf...
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FDA Device Recall: Tri-Staple 2.0 Black Intelligent Reload, Product Number SIG60AXT
2023-03-15
Class II — Affected lots have the potential for a broken sled vane, which may cause the reload to misfire leading to non-functional staple line closure, transecting tissue without forming staples, and...
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FDA Device Recall: Surgilon Braided Nylon suture Product Description: 88861883-51 SURGILON* 2-0 B
2023-03-08
Class II — Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact
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FDA Device Recall: Dermalon Monofilament Nylon Suture: (1) 88861741-11 DERMALON* 6-0 BLU 45CM C1
2023-03-08
Class II — Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact
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FDA Device Recall: Custom Suture Pack Product Description: US1638 CUSTOM SUTURE PACK US1756 CUST
2023-03-08
Class II — Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact
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FDA Device Recall: Ti-Cron Coated Braided Polyester Suture Product Description 88862775-31 TICRON
2023-03-08
Class II — Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact
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FDA Device Recall: Surgidac Uncoated Braided Polyester suture Product Description D-1764K
2023-03-08
Class II — Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact
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FDA Device Recall: Parietex Composite Mesh Polyester with Absorbable Collagen Film, Horseshoe- Sha
2023-03-08
Class II — Collagen film was placed on the opposite side of the mesh may cause delay to treatment/therapy, adhesions, erosion/migration, pain, fistula, hernia (recurrence), and failure of implant
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FDA Device Recall: Sofsilk Coated Braided Silk Suture Product Description CS-211 SOFSILK*
2023-03-08
Class II — Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact
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FDA Device Recall: Monosof Monofilament Nylon sutures: Product Description CN-724 MONOSOF* 1 BL
2023-03-08
Class II — Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact
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FDA Device Recall: Surgipro II Monofilament Polypropylene Sutures Product Description Model Number
2023-03-08
Class II — Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact
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FDA Device Recall: COVIDIEN Emprint Ablation Catheter with Thermosphere Technology, Bronchoscopic A
2023-01-18
Class II — The product is labeled with the incorrect expiration date.
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FDA Device Recall: MAHURKAR 13.5Fr High Flow Dual Lumen Acute Dialysis Catheter, Sterile, Single Us
2023-01-18
Class I — There is a potential leaking condition within the hub of affected devices, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.
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FDA Recall: Covidien Llc — Class I
20220713
There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which m | Product: Palindrome Precision Chronic Catheter,...
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FDA Recall: Covidien, LP — Class II
20220126
Prior to use on a patient, the device alarm speaker failed to annunciate on power up and the device falsely detected a sensor cable disconnect and rec | Product: SonarMed AirWave Monitor Kit (Monitor,...
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FDA Device Recall: Palindrome Precision Chronic Catheter, Sterile, Single Use, Rx Only. For vascula
2022-07-13
Class I — There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return ...
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FDA Device Recall: Palindrome Precision HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acu
2022-07-13
Class I — There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return ...
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FDA Device Recall: Palindrome H Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chron
2022-07-13
Class I — There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return ...
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FDA Device Recall: Palindrome SI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chro
2022-07-13
Class I — There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return ...
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FDA Device Recall: Mahurkar Chronic Carbothane (Maxid) Catheter, Sterile, Single Use, Rx Only. For
2022-07-13
Class I — There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return ...
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FDA Device Recall: EEA Autosuture Circular Stapler with DST Series Technology, 25mm. Model Numbers
2022-07-13
Class II — The affected staplers have the potential for the staple guide to not be securely attached to the instrument. The issue could cause the component to disengage and if disengaged, could allow ...
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FDA Device Recall: Chameleon PTA Balloon Dilation Catheter 8 mm x 40 mm, Chameleon PTA Balloon Cath
2022-02-09
Class II — The firm has received six (6) complaint reports from customers indicating difficulty removing the balloon protector sleeve from the catheter (e.g., excessive force required to remove the pr...
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FDA Device Recall: SonarMed AirWave Monitor Kit (Monitor, Sensor Cable, Power Cord), Item Code AW-M
2022-01-26
Class II — Prior to use on a patient, the device alarm speaker failed to annunciate on power up and the device falsely detected a sensor cable disconnect and reconnect during setup. The monitor detect...
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FDA Recall: Covidien Llc — Class I
20211215
Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during | Product: Puritan Bennett 980 Series Ventilator,...
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FDA Recall: Covidien Llc — Class I
20211215
Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during | Product: Puritan Bennett 980 Series Ventilator,...
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FDA Recall: Covidien Llc — Class I
20211215
Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during | Product: Puritan Bennett 980 Series Ventilator,...
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FDA Recall: Covidien, LP — Class II
20210908
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU). | Product: Palindrome Precision RT Chronic Catheter K...
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FDA Recall: Covidien, LP — Class II
20210908
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU). | Product: Palindrome Precision RT Chronic Catheter K...
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FDA Recall: Covidien, LP — Class II
20210908
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU). | Product: Palindrome RT Repair Kit 15 FR TAL 55cm, S...
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FDA Recall: Covidien, LP — Class II
20210908
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU). | Product: Palindrome Precision RT Chronic Catheter K...
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FDA Recall: Covidien, LP — Class II
20210623
The company was notified by their supplier of sterilization services for airway products in Italy of potential deviations from validated parameters fo | Product: Adult-Pediatric Electrostatic Filter H...
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FDA Recall: Covidien, LP — Class II
20210623
The company was notified by their supplier of sterilization services for airway products in Italy of potential deviations from validated parameters fo | Product: Mechanical Filter with Connector Small...
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FDA Recall: Covidien Llc — Class II
20210421
Potential for the pouch to contain an extra laminate layer, creating the potential for the device sterility to be compromised. The inclusion of an add | Product: Covidien Tri-Staple 2.0 Reinforced Int...
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FDA Recall: Covidien Llc — Class II
20210106
May contain a damaged internal component which could impede staple deployment and result in incomplete staple formation and a non-functional staple li | Product: Covidien TA Auto Suture Vascular Loadi...
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FDA Device Recall: Puritan Bennett 980 Series Ventilator, 980X2ESDIEC
2021-12-15
Class I — Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
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FDA Device Recall: Puritan Bennett 980 Series Ventilator, 980U1ESDIUC
2021-12-15
Class I — Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
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FDA Device Recall: Puritan Bennett 980 Series Ventilator, 980U1ENASAA
2021-12-15
Class I — Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
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FDA Device Recall: Covidien Sonicision Battery Charger-intended to charge the Sonicision Reusable B
2021-12-15
Class II — Intermittent risk of electric shock to users if an affected charger is used in conjunction with a faulty or bypassed institutions Mains Protective Earth (Ground) circuit
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FDA Device Recall: Puritan Bennett 980 Series Ventilator, 980X3ENDIUU
2021-12-15
Class I — Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
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FDA Device Recall: Puritan Bennett 980 Series Ventilator, 980X1ENNISB
2021-12-15
Class I — Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
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FDA Device Recall: Puritan Bennett 980 Series Ventilator, 980S3ENDICU
2021-12-15
Class I — Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
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FDA Device Recall: Puritan Bennett 980 Series Ventilator, 980A3ENNISB
2021-12-15
Class I — Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
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FDA Device Recall: Puritan Bennett 980 Series Ventilator, 980X1ENDIPC
2021-12-15
Class I — Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
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FDA Device Recall: Puritan Bennett 980 Series Ventilator, 980S1ENDICU
2021-12-15
Class I — Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
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FDA Device Recall: Puritan Bennett 980 Series Ventilator, 980X1ENDIUU
2021-12-15
Class I — Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
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FDA Device Recall: Puritan Bennett 980 Series Ventilator, 980A1ENNISB
2021-12-15
Class I — Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
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FDA Device Recall: Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 1
2021-09-08
Class II — This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
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FDA Device Recall: Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 1
2021-09-08
Class II — This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
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FDA Device Recall: Palindrome RT Repair Kit 15 FR TAL 55cm, Sterile, Item Code 8888541155
2021-09-08
Class II — This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
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FDA Device Recall: Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 1
2021-09-08
Class II — This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
View Source
FDA Device Recall: Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5
2021-09-08
Class II — This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
View Source
FDA Device Recall: Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 1
2021-09-08
Class II — This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
View Source
FDA Device Recall: Palindrome RT Repair Kit 15 FR TAL 44cm, Sterile, Item Code 8888541144
2021-09-08
Class II — This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
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FDA Device Recall: Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5
2021-09-08
Class II — This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
View Source
FDA Device Recall: Palindrome RT Repair Kit 15 FR TAL 33cm, Sterile, Item Code 8888541133
2021-09-08
Class II — This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
View Source
FDA Device Recall: Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5
2021-09-08
Class II — This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
View Source
FDA Device Recall: Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 1
2021-09-08
Class II — This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
View Source
FDA Device Recall: Palindrome RT Repair Kit 15 FR TAL 23cm, Sterile, Item Code 8888541123
2021-09-08
Class II — This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
View Source
FDA Device Recall: Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5
2021-09-08
Class II — This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
View Source
FDA Device Recall: Palindrome RT Repair Kit 15 FR TAL 19cm, Sterile, Item Code 8888541119
2021-09-08
Class II — This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
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FDA Device Recall: Adult-Pediatric Electrostatic Filter HME, Item Code 352/5877Z - Product Usage: i
2021-06-23
Class II — The company was notified by their supplier of sterilization services for airway products in Italy of potential deviations from validated parameters for ethylene oxide sterilization.
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FDA Device Recall: Mechanical Filter with Connector Small, Tethered Cap, Item Code 351/5979 - Produ
2021-06-23
Class II — The company was notified by their supplier of sterilization services for airway products in Italy of potential deviations from validated parameters for ethylene oxide sterilization.
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FDA Device Recall: Electrostatic Filter Angled, Item Code 350S19006 - Product Usage: indicated for
2021-06-23
Class II — The company was notified by their supplier of sterilization services for airway products in Italy of potential deviations from validated parameters for ethylene oxide sterilization.
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FDA Device Recall: Covidien Tri-Staple 2.0 Reinforced Intelligent Reload 60 mm Medium/Thick-For use
2021-04-21
Class II — Potential for the pouch to contain an extra laminate layer, creating the potential for the device sterility to be compromised. The inclusion of an additional laminate layer in the package m...
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FDA Device Recall: Covidien Signia Small Diameter Curved Tip Intelligent Reload 45 mm Vascular/Thin
2021-04-21
Class II — Potential for the device safety interlock to fail. The safety interlock prevents an empty single-use reload from being erroneously fired a second time. If the safety interlock fails and the...
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FDA Device Recall: Covidien Surgiwand" II Suction and Irrigation Device: Electrosurgical, cutting &
2021-04-21
Class II — Investigations related to customer complaints received for particulate matter inside of the Surgiwand" II device tubing components identified the root cause as a damaged Y-Connector compone...
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FDA Device Recall: Covidien Signia Small Diameter Curved Tip Intelligent Reload 30 mm Vascular/Thi
2021-04-21
Class II — Potential for the device safety interlock to fail. The safety interlock prevents an empty single-use reload from being erroneously fired a second time. If the safety interlock fails and the...
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FDA Device Recall: CF Delivery Dev Caps Bravo x5, FGS-0635/FGS 0636 - Product Usage: intended to be
2021-04-07
Class II — The capsule may fail to attach to the esophageal mucosa, which in turn may lead to the aspiration of the capsule. In the event of capsule aspiration, immediate intervention to remove the ca...
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FDA Device Recall: BRAVO PH CAPS DELIVERY DEV5-PK, FGS-0312/FGS-0313 - Product Usage: intended to b
2021-04-07
Class II — The capsule may fail to attach to the esophageal mucosa, which in turn may lead to the aspiration of the capsule. In the event of capsule aspiration, immediate intervention to remove the ca...
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FDA Device Recall: Covidien Parietex hydrophilic anatomical mesh 15 cm x 10 cm polyester left - Pro
2021-03-03
Class II — incorrect device is contained in the package. The packaging label indicates that the device is for left side use, the product inside the package is for right side use. Use of an opposite si...
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FDA Device Recall: Covidien TA Auto Suture Vascular Loading Unit with DST Series Technology 30 mm-
2021-01-06
Class II — May contain a damaged internal component which could impede staple deployment and result in incomplete staple formation and a non-functional staple line preventing adequate hemostasis, or l...
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FDA Device Recall: Covidien TA Auto Suture Vascular Stapler with DST Series Technology 30mm-V 3. I
2021-01-06
Class II — May contain a damaged internal component which could impede staple deployment and result in incomplete staple formation and a non-functional staple line preventing adequate hemostasis, or l...
View Source
FDA Recall: Covidien Llc — Class II
20200520
Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2¿C. Failure to correctly measure pati | Product: Dover 100% Silicone Silver-Hydrogel Co...
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FDA Recall: Covidien Llc — Class II
20200311
Sterile packaging may potentially be compromised, and use of products may result in increased risk for infection. | Product: Kits containing Covidien Force TriVerse Electrosurgical Devices. Distribute...
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FDA Recall: Covidien LLC — Class II
20200226
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots. | Product: Polysorb Braided Absorbable Suture 6/0 18" UNDYED P-10, Item Cod...
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FDA Recall: Covidien LLC — Class II
20200226
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots. | Product: Polysorb Braided Absorbable Suture 6-0 18" UNDYED SS-24 D/A, Ite...
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FDA Recall: Covidien LLC — Class II
20200226
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots. | Product: Polysorb Braided Absorbable Suture 0 30" UNDYED HOS-11, Item Cod...
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FDA Recall: Covidien LLC — Class II
20200226
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots. | Product: Polysorb Braided Absorbable Suture 2 36" VIOLET GS-24, Item Code...
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FDA Device Recall: Puritan Bennett 980 (PB980) Ventilator Series - Product Usage: for use on patien
2020-11-18
Class II — In-house lab observations and customer reports of overheating and/or thermal damage to the battery pack, create the risk of exposure to smoke or hazardous materials, which may result in bu...
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FDA Device Recall: Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 3.5 mm, Item Co
2020-10-07
Class II — The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation.
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FDA Device Recall: Covidien Best Practices Procedure Kits containing Auto Suture Endo GIA Universal
2020-10-07
Class II — The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation.
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FDA Device Recall: Endo GIA Auto Suture Universal Loading Unit 45 mm - 2.5mm, Item Code 030454 - Pr
2020-10-07
Class II — The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation.
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FDA Device Recall: Endo GIA Auto Suture Gray Universal Articulating Loading Unit 30 mm - 2.0 mm, It
2020-10-07
Class II — The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation.
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FDA Device Recall: Endo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 2.0 mm, Item Co
2020-10-07
Class II — The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation.
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FDA Device Recall: Beacon EUS Access System Preloaded Access 135degree Needle sterile, single-use,
2020-08-12
Class II — This voluntary recall is being conducted following three customer reports of the device cannula detaching during a procedure. In one case, the detached cannula was not retrieved during the ...
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FDA Device Recall: Multifire VersaTrack Auto Suture Hernia Stapler, 4.0mm, Part No. 174021 - Produc
2020-06-10
Class II — The product is recalled due to a manufacturing assembly error that may cause the staples to fail to properly advance within the staple cartridge when the instrument handle is compressed.
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FDA Device Recall: Multifire Endo Hernia 0 12mm Stapler with 4.8mm Disposable Loading Unit , Part N
2020-06-10
Class II — The product is recalled due to a manufacturing assembly error that may cause the staples to fail to properly advance within the staple cartridge when the instrument handle is compressed.
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FDA Device Recall: Dover 100% Silicone Silver-Hydrogel Coated Foley Catheter with Temperature Senso
2020-05-20
Class II — Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2¿C. Failure to correctly measure patient body temperatures could lead to an...
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FDA Device Recall: Dover 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray 400mL,
2020-05-20
Class II — Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2¿C. Failure to correctly measure patient body temperatures could lead to an...
View Source
FDA Device Recall: Dover 100% Silicone Premium Urine Meter Foley Tray, 400mL, 14 Fr/Ch (4.7 mm), 5
2020-05-20
Class II — Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2¿C. Failure to correctly measure patient body temperatures could lead to an...
View Source
FDA Device Recall: Dover 400mL, 100% Silicone Premium Urine Meter Foley Tray, 16 Fr/Ch (5.3 mm), 5
2020-05-20
Class II — Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2¿C. Failure to correctly measure patient body temperatures could lead to an...
View Source
FDA Device Recall: Dover 400 ml 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray
2020-05-20
Class II — Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2¿C. Failure to correctly measure patient body temperatures could lead to an...
View Source
FDA Device Recall: Dover 100% Silicone Silver-Hydrogel Coated Foley Catheter with Temperature Senso
2020-05-20
Class II — Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2¿C. Failure to correctly measure patient body temperatures could lead to an...
View Source
FDA Device Recall: Dover 100% Silicone Foley Catheter with Temperature 16FR 5CC2W, Product Code: 5
2020-05-20
Class II — Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2¿C. Failure to correctly measure patient body temperatures could lead to an...
View Source
FDA Device Recall: Kits containing Covidien Force TriVerse Electrosurgical Devices. Distributed in
2020-03-11
Class II — Sterile packaging may potentially be compromised, and use of products may result in increased risk for infection.
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FDA Device Recall: Polysorb Braided Absorbable Suture 6/0 18" UNDYED P-10, Item Code SL1625G - Prod
2020-02-26
Class II — There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
View Source
FDA Device Recall: Polysorb Braided Absorbable Suture 6-0 18" UNDYED SS-24 D/A, Item Code L2752K -
2020-02-26
Class II — There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
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FDA Device Recall: Polysorb Braided Absorbable Suture 0 30" UNDYED HOS-11, Item Code CL537 - Produc
2020-02-26
Class II — There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
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FDA Device Recall: Polysorb Braided Absorbable Suture 2 36" VIOLET GS-24, Item Code CL911 - Product
2020-02-26
Class II — There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
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FDA Device Recall: Polysorb Braided Absorbable Suture 4/0 30 VIO SC-2 124K, Item Code SL654 - Produ
2020-02-26
Class II — There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
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FDA Device Recall: Polysorb Braided Absorbable Suture 3/0 30" UNDYED V-20, Item Code GLS322 - Produ
2020-02-26
Class II — There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
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FDA Device Recall: Biosyn Monofilament Absorbable Suture 6/0 30" VIOLET CV-23, Item Code UM201
2020-02-26
Class II — There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
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FDA Device Recall: Polysorb Braided Absorbable Suture 2/0 30 VIOLET GS-21, Item Code CL811 - Produc
2020-02-26
Class II — There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
View Source
FDA Device Recall: Polysorb Braided Absorbable Suture 3/0 30 VIOLET GS-11, Item Code CL815 - Produc
2020-02-26
Class II — There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
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FDA Device Recall: Covidien Endo GIA Ultra Universal Stapler 12 mm-intended for resection, transect
2020-02-26
Class II — Potential for the sterile barrier to be compromised. Products with a compromised sterile barrier may result in a potentially increased risk for infection
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FDA Device Recall: Polysorb Braided Absorbable Suture 2-0 UNDYED 30" V-20, Item Code GL323 - Produc
2020-02-26
Class II — There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
View Source
FDA Device Recall: Polysorb Braided Absorbable Suture 1 30 VIOLET GS-22, Item Code CL885 - Product
2020-02-26
Class II — There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
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FDA Device Recall: Polysorb Braided Absorbable Suture 6/0 12"" VL SS-24 D/A, Item Code L1742K - Pro
2020-02-26
Class II — There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
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FDA Device Recall: Polysorb Braided Absorbable Suture 4/0 30 VIOLET CVF23, Item Code UL203 - Produc
2020-02-26
Class II — There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
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FDA Device Recall: Polysorb Braided Absorbable Suture 3/0 VIOLET 30" CV-24 (75CM), Item Code CL461
2020-02-26
Class II — There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
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FDA Device Recall: Polysorb Braided Absorbable Suture 0 36 VIOLET GS-24, Item Code CL914 - Product
2020-02-26
Class II — There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
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FDA Device Recall: Polysorb Braided Absorbable Suture 0 30" VIOLET GU-46, Item Code UL877 - Product
2020-02-26
Class II — There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
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FDA Device Recall: Polysorb Braided Absorbable Suture 2/0 30"VIOLET GU-46, Item Code UL878 - Produc
2020-02-26
Class II — There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
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FDA Device Recall: Polysorb Braided Absorbable Suture 13-0 VIOLET 30" GS-23, Item Code CL892 - Prod
2020-02-26
Class II — There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
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FDA Device Recall: Polysorb Braided Absorbable Suture 2/0 UNDYED 30" V-30 (75CM), Item Code GL228 -
2020-02-26
Class II — There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
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FDA Device Recall: Polysorb Braided Absorbable Suture 2-0 VIOLET 30" V-20, Item Code GL123 - Produc
2020-02-26
Class II — There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
View Source
FDA Device Recall: Polysorb Braided Absorbable Suture 2-0 VIOLET 36" GS-21, Item Code CL923 - Produ
2020-02-26
Class II — There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
View Source
FDA Device Recall: Polysorb Braided Absorbable Suture 2-0 UNDYED 36" GS-21, Item Code CL953 - Produ
2020-02-26
Class II — There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
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FDA Device Recall: Polysorb Braided Absorbable Suture 0 VIOLET 30" V-20, Item Code GL124 - Product
2020-02-26
Class II — There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
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FDA Device Recall: Polysorb Braided Absorbable Suture UD 3/0 30 P-14, Item Code SL5679 - Product Us
2020-02-26
Class II — There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
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FDA Recall: Covidien LLC — Class II
20190626
The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lea | Product: EGIA 45 ARTICULATING XTRA THICK SULU, ...
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FDA Recall: COVIDIEN LLC — Class II
20190501
Sterilization method used was not consistent with the labeling and the approved sterilization method | Product: Covidien Endo Clinch II Auto Suture Grasper, 5mm REF: 174317 The Covidien Endo Cli...
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FDA Device Recall: MAHURKAR and Argyle acute hemodialysis catheters, Material numbers 8813793009 8
2019-07-17
Class II — The priming volume values printed on the MAHURKA and Argyle acute catheters and Instructions for Use (IFU) are higher than the volumes required to fill each lumen.
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FDA Device Recall: EGIA 45 ARTICULATING XTRA THICK SULU, Item Code EGIA45AXT
2019-06-26
Class II — The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, perito...
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FDA Device Recall: SIGNIA TRI-STAPLE 2.0 CURVED TIP 45MM MEDIUM/ THIC , SIG45CTAMT
2019-06-26
Class II — The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, perito...
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FDA Device Recall: SIGNIA TRI-STAPLE 2.0 30MM MEDIUM/ THICK RELOAD , SIG30AMT
2019-06-26
Class II — The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, perito...
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FDA Device Recall: EGIA 45 ARTICULATING MED THICK SULU, Item Code EGIA45AMT
2019-06-26
Class II — The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, perito...
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FDA Device Recall: EGIA 30 ARTICULATING MED THICK SULU, Item Code EGIA30AMT
2019-06-26
Class II — The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, perito...
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FDA Device Recall: SIGNIA TRI-STAPLE 2.0 BLACK 60MM EXTRA THICK RELOA, SIG60AXT
2019-06-26
Class II — The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, perito...
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FDA Device Recall: EGIA 60 CURVED TIP ART MED THICK SULU, EGIA60CTAMT
2019-06-26
Class II — The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, perito...
View Source
FDA Device Recall: EGIA 60 ARTICULATING EXTRA THICK SULU, Item code EGIA60AXT
2019-06-26
Class II — The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, perito...
View Source
FDA Device Recall: SIGNIA TRI-STAPLE 2.0 CURVED TIP 60MM MEDIUM/ THIC , SIG60CTAMT
2019-06-26
Class II — The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, perito...
View Source
FDA Device Recall: Covidien Endo Clinch II Auto Suture Grasper, 5mm REF: 174317 The Covidien
2019-05-01
Class II — Sterilization method used was not consistent with the labeling and the approved sterilization method
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FDA Device Recall: Covidien Endo Grasp Auto Suture Grasper 5mm REF: 173030 The Covidien Endo Gr
2019-05-01
Class II — Sterilization method used was not consistent with the labeling and the approved sterilization method
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FDA Device Recall: Procedure kits include devices from the affected lots distributed OUS only: (1)
2019-05-01
Class II — Sterilization method used was not consistent with the labeling and the approved sterilization method
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FDA Device Recall: Kendall SCD Express Sterile Sleeves (Thigh Length), Model Number 9736
2019-04-03
Class II — The product does not meet sterility requirements. Product labeled as sterile was distributed without undergoing sterilization prior to distribution.
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FDA Device Recall: Covidien Force TriVerse electrosurgical device 10 cord-Intended as electrosurgi
2019-03-27
Class II — Potential for the sterile packaging to be compromised
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FDA Recall: COVIDIEN LLC — Class II
20181010
Potential for product sterility breach due to a compromised or pinched seal defect | Product: Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716 Product Usa
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FDA Recall: Covidien LLC — Class II
20180404
Product reportedly shutting down during use. | Product: Signia" Power Handle (SIGPHANDLE, SIGNVAL1 and SIGVAL20 - Kits) The Signia" Power Handle, when us
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FDA Recall: Covidien LP — Class II
20180214
Medtronic is voluntarily recalling two production lots of its Covidien Vistec" x-ray detectable sponges de to possible contamination with human blood | Product: Covidien Vistec" X-Ray Detectable Spon...
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FDA Device Recall: Covidien Emprint Standard Percutaneous Antenna with Thermosphere Technology, CA2
2018-12-26
Class II — The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip remaining in the pa...
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FDA Device Recall: Covidien Emprint Long Percutaneous Antenna with Thermosphere Technology, Materia
2018-12-26
Class II — The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip remaining in the pa...
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FDA Device Recall: Covidien Emprint Short Percutaneous Antenna with Thermosphere Technology, Materi
2018-12-26
Class II — The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip remaining in the pa...
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FDA Device Recall: 8Fr SAFE GRAD CAT W/Valve (Argyle Suction Catheter Kits with Chimney Valve), Mod
2018-12-26
Class II — The product was released into commercial distribution while subject to importation refusal.
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FDA Device Recall: Puritan Bennett 980 (PB980) ventilator series: Puritan Bennett" 980 Pediatric
2018-12-26
Class I — Software Update: External USB Drive performance and its impact on Graphic User Interface (GUI) functionality and labeling of the scalar waveform displayed on GUI during ventilation
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FDA Device Recall: Parietex Composite Parastomal Mesh (Product Number PCOPM15 / PCOPM20) Product
2018-11-21
Class II — The firm is issuing this voluntary removal following receipt of reports of parastomal mesh failure identified several years following parastomal hernia repair using the modified Sugarbaker ...
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FDA Device Recall: Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF
2018-10-10
Class II — Potential for product sterility breach due to a compromised or pinched seal defect
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FDA Device Recall: Dermacea Gauze Fluff Roll, 6 Ply, 4 x 4-1/8 yd (10.2 cm x 3.7 m), REF 441106
2018-10-10
Class II — Potential for product sterility breach due to a compromised or pinched seal defect
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FDA Device Recall: Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m)
2018-10-10
Class II — Potential for product sterility breach due to a compromised or pinched seal defect
View Source
FDA Device Recall: Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441103
2018-10-10
Class II — Potential for product sterility breach due to a compromised or pinched seal defect
View Source
FDA Device Recall: Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF
2018-10-10
Class II — Potential for product sterility breach due to a compromised or pinched seal defect
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FDA Device Recall: P400 PREM U/M 18FR TMPSNS, Item Code P4P18TS
2018-09-26
Class II — The temperature sensor catheters may be defective in that they will show a lower body temperature measurement than the actual temperature of the patient.
View Source
FDA Device Recall: 400mL, Premium, Urine Meter, 14 FR, Silicone Temperature Sensing Foley Traywith
2018-09-26
Class II — The temperature sensor catheters may be defective in that they will show a lower body temperature measurement than the actual temperature of the patient.
View Source
FDA Device Recall: 400mL, Premium, Urine Meter, 16 FR, Silicone Temperature Sensing Foley Traywith
2018-09-26
Class II — The temperature sensor catheters may be defective in that they will show a lower body temperature measurement than the actual temperature of the patient.
View Source
FDA Device Recall: Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems. Product
2018-09-05
Class II — Revised replacement instructions for the Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems
View Source
FDA Device Recall: Polysorb Braided Absorbable Suture 1 36" 90 cm Undyed GS-21, Product Number CL-
2018-08-08
Class II — Potential proplylene glycol contamination
View Source
FDA Device Recall: EEA" Hemorrhoid and Prolapse Stapler Set with DST Series" Technology 3.5MM, Prod
2018-05-02
Class II — There is a potential for improper welding of the yellow staple guide to the instrument. Use of a device with an improperly welded staple guide may result in improper staple formation potent...
View Source
FDA Device Recall: Signia" Power Handle (SIGPHANDLE, SIGNVAL1 and SIGVAL20 - Kits) The Signia" P
2018-04-04
Class II — Product reportedly shutting down during use.
View Source
FDA Device Recall: Rechargeable Li-ion battery used with Puritan Bennett TM 980 Series Ventilator S
2018-04-04
Class II — Rechargeable lithium-ion batteries with incorrect firmware that are used in certain Puritan Bennett 980 ventilators may not fully charge after installation.
View Source
FDA Device Recall: Situate Gauze RF and X-Ray detectable. Product Number: G0804-16P02CN-1 Situa
2018-03-28
Class II — This voluntary recall is being conducted due to the potential for failure to detect the affected Situate" gauze - RF and Xray detectable products by the Situate" detection console due to...
View Source
FDA Device Recall: GastriSail" Gastric Positioning Device Product Usage: The GastriSail gastric
2018-02-28
Class II — Reports of gastric or esophageal perforation occurring in procedures where the GastriSail" Gastric Positioning device has been used.
View Source
FDA Device Recall: Covidien Vistec" X-Ray Detectable Sponges, 7317 Vistec" X-Ray Detectable Sponges
2018-02-14
Class II — Medtronic is voluntarily recalling two production lots of its Covidien Vistec" x-ray detectable sponges de to possible contamination with human blood caused by handling of the product durin...
View Source
FDA Device Recall: Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 30cm, Materi
2018-02-14
Class II — The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip remaining in the pat...
View Source
FDA Device Recall: Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 20cm (reinfo
2018-02-14
Class II — The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip remaining in the pat...
View Source
FDA Device Recall: Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 30cm (reinfo
2018-02-14
Class II — The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip remaining in the pat...
View Source
FDA Recall: Covidien LLC — Class II
20170412
Product sterility is compromised due to breach of sterile barrier | Product: Covidien Curity Wet Dressing 8 x 4 (20.3 cm x 10.2 cm), Sterile Item Code: 3337 Curity sodium
View Source
FDA Recall: Covidien LLC — Class II
20170412
Product sterility is compromised due to breach of sterile barrier | Product: Covidien Curity Eye Pad Item Code: 91650 The sterile eye pad is a device that consists of a pad m
View Source
FDA Recall: Covidien LLC — Class II
20170315
Sterility compromised due to breach in sterile barrier | Product: Premier Guard Drape, Sterile. For Use with Verisphere (01-0035) and ArQ.Sphere (01-0044) Item Nu
View Source
FDA Recall: Covidien LLC — Class II
20170208
Labeling error: The label indicates the product is latex free, but the headband component included with the forehead sensor does contain latex. | Product: Covidien Nellcor SpO2 Forehead Sensor Item C...
View Source
FDA Device Recall: Covidien Curity Wet Dressing 8 x 4 (20.3 cm x 10.2 cm), Sterile Item Code: 3
2017-04-12
Class II — Product sterility is compromised due to breach of sterile barrier
View Source
FDA Device Recall: Covidien Curity Eye Pad Item Code: 91650 The sterile eye pad is a device that
2017-04-12
Class II — Product sterility is compromised due to breach of sterile barrier
View Source
FDA Device Recall: Covidien Curity Eye Pad Item Code: 03201 The sterile eye pad is a device that
2017-04-12
Class II — Product sterility is compromised due to breach of sterile barrier
View Source
FDA Device Recall: Covidien Curity Saline Dressing 8' x 4 (20.3cm x10.2 cm), Sterile Item Code: 3
2017-04-12
Class II — Product sterility is compromised due to breach of sterile barrier
View Source
FDA Device Recall: Premier Guard Drape, Sterile. For Use with Verisphere (01-0035) and ArQ.Sphere
2017-03-15
Class II — Sterility compromised due to breach in sterile barrier
View Source
FDA Device Recall: Premier Guard Sterile Drape For Use with Blair-Port Wand (02-0029) and Blair-Por
2017-03-15
Class II — Sterility compromised due to breach in sterile barrier
View Source
FDA Device Recall: Covidien Nellcor SpO2 Forehead Sensor Item Code: RS10; The Covidien Nellcor¿
2017-02-08
Class II — Labeling error: The label indicates the product is latex free, but the headband component included with the forehead sensor does contain latex.
View Source
FDA Recall: Covidien LLC — Class II
20161116
Added Instructions for Use: After application, inspect the Light Glove for barrier integrity | Product: Professional Hospital Supply, Inc Custom Packaging containing the Devon Light Glove Item Numbe...
View Source
FDA Recall: Covidien LLC — Class II
20160608
Compromised sterility due to breach of barrier | Product: Vistec X-Ray Detectable Sponges, 16 Ply, 8" x 4" (20.3 cm x 10.2 cm) Item Number: 7319
View Source
FDA Recall: Covidien LLC — Class II
20160608
Compromised sterility due to breach of barrier | Product: Curity X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 12" x 12" (30.5 cm x 30.5 cm) Item Num
View Source
FDA Recall: Covidien LLC — Class II
20160608
Compromised sterility due to breach of barrier | Product: Curity All Purpose Sponges, Non-woven, 4 Ply, Soft Pouch, 4" x 4" (10.2 cm x 10.2 cm) Item Number:
View Source
FDA Recall: Covidien LLC — Class II
20160330
Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria | Product: Covidien Dover PREM U/M 14FR TMP SNS CSD Item Code: P4P14TSD P400...
View Source
FDA Recall: Covidien LLC — Class II
20160330
Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria | Product: Covidien Dover P400 PREM U/M 16FR SLVR FLY Item Code: P4P16XSD C...
View Source
FDA Recall: Covidien LLC — Class II
20160330
Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria | Product: Covidien Dover PPREM 18FR UL LTX FOLEY TRY CSD Item Code: P18UL...
View Source
FDA Recall: Covidien LLC — Class II
20160330
Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria | Product: Covidien Dover P400 PREM U/M 18FR SIL COUDE CATH SECURE Item Code...
View Source
FDA Recall: Covidien LLC — Class II
20160330
Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria | Product: Covidien Dover 400 PREM U/M 18FR SLVR FLY Item Code: ¿¿¿ P4P18XSD...
View Source
FDA Recall: Covidien LLC — Class II
20160330
Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria | Product: Covidien Dover P400 PREM U/M 16FR UL FOLY CSD Item Code:P4P16ULD ...
View Source
FDA Device Recall: Professional Hospital Supply, Inc Custom Packaging containing the Devon Light Gl
2016-11-16
Class II — Added Instructions for Use: After application, inspect the Light Glove for barrier integrity
View Source
FDA Device Recall: Covidien Cytosponge Cell Collection Kit. Contains Cytosponge Cell Collection De
2016-07-13
Class II — Medtronic is recalling all lots of the Covidien Cytosponge Cell Collection device after two reports of the device detaching from the removal string during withdrawal from the patient's esop...
View Source
FDA Device Recall: Vistec X-Ray Detectable Sponges, 16 Ply, 8" x 4" (20.3 cm x 10.2 cm) Item Numbe
2016-06-08
Class II — Compromised sterility due to breach of barrier
View Source
FDA Device Recall: Curity X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 12" x 12" (30.5 cm
2016-06-08
Class II — Compromised sterility due to breach of barrier
View Source
FDA Device Recall: Curity All Purpose Sponges, Non-woven, 4 Ply, Soft Pouch, 4" x 4" (10.2 cm x 10.
2016-06-08
Class II — Compromised sterility due to breach of barrier
View Source
FDA Device Recall: Curity X-Ray Detectable Laparotomy Sponges, Tray Pack, 8" x 36" (20.3 cm x 91.4
2016-06-08
Class II — Compromised sterility due to breach of barrier
View Source
FDA Device Recall: Vistec X-Ray Detectable Sponges, 26 Ply, 8" x 4" (20.3 cm x 10.2 cm) Item Numbe
2016-06-08
Class II — Compromised sterility due to breach of barrier
View Source
FDA Device Recall: Curity X-Ray Detectable Laparotomy Sponges, Tray Pack, 18" x 18" (45.7 cm x 45.7
2016-06-08
Class II — Compromised sterility due to breach of barrier
View Source
FDA Device Recall: Kerlix" X-Ray Detectable Laparotomy Sponges, Tray Pack, 8" x 32" (20.3 cm x 81.3
2016-06-08
Class II — Compromised sterility due to breach of barrier
View Source
FDA Device Recall: Given Imaging Bravo¿ pH capsule delivery device, 5-pack. In-Vitro Diagnostic fo
2016-05-18
Class II — Potential of an allergic reaction in a patient with nickel sensitivity.
View Source
FDA Device Recall: Given Imaging Bravo¿¿ pH capsule delivery device, 1-pack. In- Vitor Diagnostic
2016-05-18
Class II — Potential of an allergic reaction in a patient with nickel sensitivity.
View Source
FDA Device Recall: Covidien Dover PREM U/M 14FR TMP SNS CSD Item Code: P4P14TSD P400 Castile s
2016-03-30
Class II — Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
View Source
FDA Device Recall: Covidien Dover P400 PREM U/M 16FR SLVR FLY Item Code: P4P16XSD Castile soap
2016-03-30
Class II — Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
View Source
FDA Device Recall: Covidien Dover PPREM 18FR UL LTX FOLEY TRY CSD Item Code: P18ULD Castile
2016-03-30
Class II — Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
View Source
FDA Device Recall: Covidien Dover P400 PREM U/M 18FR SIL COUDE CATH SECURE Item Code: P4P18CSD
2016-03-30
Class II — Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
View Source
FDA Device Recall: Covidien Dover 400 PREM U/M 18FR SLVR FLY Item Code: ¿¿¿ P4P18XSD Castile so
2016-03-30
Class II — Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
View Source
FDA Device Recall: Covidien Dover P400 PREM U/M 16FR UL FOLY CSD Item Code:P4P16ULD Castile soa
2016-03-30
Class II — Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
View Source
FDA Device Recall: Covidien Dover P400 PREM U/M 16FR SIL COUDE CATH SECURE Item Code: P4P16CSD
2016-03-30
Class II — Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
View Source
FDA Device Recall: Covidien Dover PRECSION PRM 16FR SIL FLY Item Code: PP16SD Castile soap tow
2016-03-30
Class II — Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
View Source
FDA Device Recall: Covidien Dover PRECISION PRM 18FR SIL COUDE CATH SECURE Item Code: PP18CSD
2016-03-30
Class II — Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
View Source
FDA Device Recall: Covidien Dover PREC PRM 16FR SILVER FLY TY Item Code: PP16XSD Castile soap
2016-03-30
Class II — Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
View Source
FDA Device Recall: Covidien Dover P400 UM 18FR SIL COUDE SECURE Item Code: P4P18CSDK Castile s
2016-03-30
Class II — Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
View Source
FDA Device Recall: Covidien Dover 7 OZ MIDSTREAM W/CAST SOAP Item Code: 24035 Castile soap towe
2016-03-30
Class II — Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
View Source
FDA Device Recall: Covidien Dover EASY CATCH MIDSTREAM KT W/CAST Item Code: 25015 Castile soap
2016-03-30
Class II — Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
View Source
FDA Device Recall: Covidien Dover P400 UM 16FR SIL COUDE SECURE Item Code: P4P16CSDK Castile so
2016-03-30
Class II — Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
View Source
FDA Device Recall: Covidien Dover P400 PREM U/M 16FR TMP SNS CSD Item Code: P4P16TSD Castile soa
2016-03-30
Class II — Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
View Source
FDA Device Recall: Covidien Dover PREC PRM 14FR SILVER FLY TY Item Code: PP14XSD ¿ ¿¿ Castile
2016-03-30
Class II — Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
View Source
FDA Device Recall: Covidien Dover P400 PREM U/M 18FR SIL FLY Item Code: P4P18SD Castile soap
2016-03-30
Class II — Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
View Source
FDA Device Recall: Covidien Dover 4.5OZ MIDSTREAM W/CASTILE TOWL Item Code: 24015 Castile soap
2016-03-30
Class II — Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
View Source
FDA Device Recall: Covidien Dover P400 PREM U/M 18FR UL FOLY CSD Item Code: P4P18ULD Castile s
2016-03-30
Class II — Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
View Source
FDA Device Recall: Covidien Dover P400 PREM U/M 16FR SIL FLY Item Code: P4P16SD Castile soap tow
2016-03-30
Class II — Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
View Source
FDA Device Recall: Covidien Dover MIDSTREAM KIT RING CASTILE Item Code: 4090SA Castile soap tow
2016-03-30
Class II — Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
View Source
FDA Device Recall: Covidien Dover PRECISION PRM 16FR SIL COUDE CATH SECURE Item Code: PP16CSD Ca
2016-03-30
Class II — Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
View Source
FDA Device Recall: Covidien Kangaroo Polyurethane Feeding Tube Radiopaque Line, Safe Enteral Connec
2016-03-09
Class II — 8FR 16 PVC tubes were packaged in a 6.5 FR 36 Polyurethane packs and 8FR 20 PVC tubes were packaged in an 8FR 20 Polyurethane packs
View Source
FDA Device Recall: Covidien Kangaroo Polyurethane Feeding Tube Radiopaque Line, Safe Enteral Connec
2016-03-09
Class II — 8FR 16 PVC tubes were packaged in a 6.5 FR 36 Polyurethane packs and 8FR 20 PVC tubes were packaged in an 8FR 20 Polyurethane packs
View Source
FDA Recall: Covidien LLC — Class II
20151202
Incorrectly packaged with a 90 degree bend at the distal tip | Product: Palindrome Precision Chronic Catheter Kit Symmetrical Tip 14.5 Fr/Ch (4.8mm) X 33 cm Item Number:
View Source
FDA Recall: Covidien LLC — Class II
20150909
Sterility may be compromised | Product: Monoject 0.9% Saline Flush Prefill Double Pouch Item Code: 8881570129 Product Usage: Sterile Deli
View Source
FDA Recall: Covidien LLC — Class II
20150909
Multi-Function Defibrillation Electrodes, Pre connect- potential for damage to the wire insulation may result in a potentially increased risk for | Product: MediTrace Cadence Adult Zoll, Preconne...
View Source
FDA Recall: Covidien LLC — Class II
20150909
Sterility may be compromised | Product: MAHURKAR 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16cm, Curved Extensions, PASS Tray
View Source
FDA Recall: Covidien LLC — Class II
20150729
Devon Light Gloves contain splits or holes compromising the sterility | Product: ASC (Breast) Kit, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Decription: 5733
View Source
FDA Recall: Covidien LLC — Class II
20150708
Catheters may not meet antimicrobial specification | Product: Palindrome Precision SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 888
View Source
FDA Recall: Covidien LLC — Class II
20150708
Catheters may not meet antimicrobial specification | Product: Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145063
View Source
FDA Recall: Covidien LLC — Class II
20150708
Catheters may not meet antimicrobial specification | Product: Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 888814504
View Source
FDA Recall: Covidien LLC — Class II
20150708
Catheters may not meet antimicrobial specification | Product: Palindrome SI Chronic Catheter Kit 14.5 Fr x 28cm Item Code: 8888245064
View Source
FDA Recall: Covidien LLC — Class II
20150708
Catheters may not meet antimicrobial specification | Product: Palindrome Precision HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 88
View Source
FDA Device Recall: Palindrome Precision Chronic Catheter Kit Symmetrical Tip 14.5 Fr/Ch (4.8mm) X
2015-12-02
Class II — Incorrectly packaged with a 90 degree bend at the distal tip
View Source
FDA Device Recall: Palindrome" Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Stylet 14.5 Fr/
2015-12-02
Class II — Incorrectly packaged with a 90 degree bend at the distal tip
View Source
FDA Device Recall: Palindrome Precision Chronic Catheter Kit Symmetrical Tip, Pre-Curved Shaft and
2015-12-02
Class II — Incorrectly packaged with a 90 degree bend at the distal tip
View Source
FDA Device Recall: Palindrome Precision Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Stylet
2015-12-02
Class II — Incorrectly packaged with a 90 degree bend at the distal tip
View Source
FDA Device Recall: Monoject 0.9% Saline Flush Prefill Double Pouch Item Code: 8881570129 Product
2015-09-09
Class II — Sterility may be compromised
View Source
FDA Device Recall: MediTrace Cadence Adult Zoll, Preconnect Defibrillation Electrode, Nonsterile
2015-09-09
Class II — Multi-Function Defibrillation Electrodes, Pre connect- potential for damage to the wire insulation may result in a potentially increased risk for reduced or no patient therapy and patie...
View Source
FDA Device Recall: MAHURKAR 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16cm, Curved E
2015-09-09
Class II — Sterility may be compromised
View Source
FDA Device Recall: Mahurkar Acute Dual Lumen Catheter Tray, High Flow¿ Pre-Curved with IC* Safety C
2015-09-09
Class II — Sterility may be compromised
View Source
FDA Device Recall: Physio-Control QuikCombo Pacing/Defibrillation/ECG Electrodes RediPak¿ Preconn
2015-09-09
Class II — Multi-Function Defibrillation Electrodes, Pre connect- potential for damage to the wire insulation may result in a potentially increased risk for reduced or no patient therapy and patie...
View Source
FDA Device Recall: Mahurkar Elite Acute Triple Lumen Catheter Tray, Curved Extensions with IC* Safe
2015-09-09
Class II — Sterility may be compromised
View Source
FDA Device Recall: Mahurkar Elite Acute Dual Lumen Catheter Tray, High Flow Straight Extensions wit
2015-09-09
Class II — Sterility may be compromised
View Source
FDA Device Recall: MAHURKAR"* 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20cm, Curved
2015-09-09
Class II — Sterility may be compromised
View Source
FDA Device Recall: MediTrace Cadence Adult Multi-Function Defibrillation Electrodes Item Code:2255
2015-09-09
Class II — Multi-Function Defibrillation Electrodes, Pre connect- potential for damage to the wire insulation may result in a potentially increased risk for reduced or no patient therapy and patie...
View Source
FDA Device Recall: Mahurkar Elite Acute Dual Lumen Catheter Tray, High Flow Pre-Curved with IC* Saf
2015-09-09
Class II — Sterility may be compromised
View Source
FDA Device Recall: MAHURKAR 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20cm, Straight
2015-09-09
Class II — Sterility may be compromised
View Source
FDA Device Recall: Covidien Argyle Infant Heel Warmers (with tab) Item Code: MH00002T Product U
2015-09-02
Class II — Infant Heel warmers may break during activation resulting in spillage of the contents on patients or healthcare worker causing potential skin/eye irritations
View Source
FDA Device Recall: Covidien Argyle Infant Heel Warmers (no tab) Item Code: MH00002N Product Usa
2015-09-02
Class II — Infant Heel warmers may break during activation resulting in spillage of the contents on patients or healthcare worker causing potential skin/eye irritations
View Source
FDA Device Recall: ASC (Breast) Kit, Sterile-Kits containing the Devon Light Glove Catalog Numbe
2015-07-29
Class II — Devon Light Gloves contain splits or holes compromising the sterility
View Source
FDA Device Recall: Single Basin Kits, Sterile-.Kits containing the Devon Light Glove Catalog Num
2015-07-29
Class II — Devon Light Gloves contain splits or holes compromising the sterility
View Source
FDA Device Recall: Covidien Devon Light Gloves, Sterile-Single Units A disposable, sterile, singl
2015-07-29
Class II — Devon Light Gloves contain splits or holes compromising the sterility
View Source
FDA Device Recall: Non Sterile Subassembly: Catalog Number/Description: SA1008 NONSTERILE SUBASS
2015-07-29
Class II — Devon Light Gloves contain splits or holes compromising the sterility
View Source
FDA Device Recall: Double Basin Kit ,Sterile-Kits containing the Devon Light Glove Catalog Numbers
2015-07-29
Class II — Devon Light Gloves contain splits or holes compromising the sterility
View Source
FDA Device Recall: Minor Surgical Kits, Sterile-Kits containing the Devon Light Glove Catalog Numb
2015-07-29
Class II — Devon Light Gloves contain splits or holes compromising the sterility
View Source
FDA Device Recall: Augmentation Kit , Sterile-.Kits containing the Devon Light Glove Catalog Numbe
2015-07-29
Class II — Devon Light Gloves contain splits or holes compromising the sterility
View Source
FDA Device Recall: Major Kit, Sterile-.Kits containing the Devon Light Glove Catalog Number:Desc
2015-07-29
Class II — Devon Light Gloves contain splits or holes compromising the sterility
View Source
FDA Device Recall: Palindrome Precision SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x
2015-07-08
Class II — Catheters may not meet antimicrobial specification
View Source
FDA Device Recall: Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm I
2015-07-08
Class II — Catheters may not meet antimicrobial specification
View Source
FDA Device Recall: Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm
2015-07-08
Class II — Catheters may not meet antimicrobial specification
View Source
FDA Device Recall: Palindrome SI Chronic Catheter Kit 14.5 Fr x 28cm Item Code: 8888245064
2015-07-08
Class II — Catheters may not meet antimicrobial specification
View Source
FDA Device Recall: Palindrome Precision HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x
2015-07-08
Class II — Catheters may not meet antimicrobial specification
View Source
FDA Device Recall: Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm
2015-07-08
Class II — Catheters may not meet antimicrobial specification
View Source
FDA Device Recall: Palindrome HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 19cm Ite
2015-07-08
Class II — Catheters may not meet antimicrobial specification
View Source
FDA Device Recall: Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code:
2015-07-08
Class II — Catheters may not meet antimicrobial specification
View Source
FDA Device Recall: Palindrome SI Chronic Catheter Kit 14.5 Fr x 19cm Item Code: 8888245062 The Pa
2015-07-08
Class II — Catheters may not meet antimicrobial specification
View Source
FDA Device Recall: Palindrome HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm Ite
2015-07-08
Class II — Catheters may not meet antimicrobial specification
View Source
FDA Device Recall: Palindrome Precision SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x
2015-07-08
Class II — Catheters may not meet antimicrobial specification
View Source
FDA Device Recall: Palindrome Precision SI Chronic Catheter Kit 14.5 Fr x 55cm Item Code: 88881450
2015-07-08
Class II — Catheters may not meet antimicrobial specification
View Source
FDA Device Recall: Palindrome SI Chronic Catheter Sport Pack 14.5 Fr x 23 cm Item Code: 8888223408
2015-07-08
Class II — Catheters may not meet antimicrobial specification
View Source
FDA Device Recall: Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code:
2015-07-08
Class II — Catheters may not meet antimicrobial specification
View Source
FDA Device Recall: Palindrome Precision HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x
2015-07-08
Class II — Catheters may not meet antimicrobial specification
View Source
FDA Device Recall: Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm I
2015-07-08
Class II — Catheters may not meet antimicrobial specification
View Source
FDA Device Recall: Palindrome SI Chronic Catheter Sport Pack 14.5 Fr x 33 cm Item Code: 8888233508
2015-07-08
Class II — Catheters may not meet antimicrobial specification
View Source
FDA Device Recall: Palindrome Precision SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x
2015-07-08
Class II — Catheters may not meet antimicrobial specification
View Source
FDA Device Recall: Palindrome Precision SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x
2015-07-08
Class II — Catheters may not meet antimicrobial specification
View Source
FDA Device Recall: Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm I
2015-07-08
Class II — Catheters may not meet antimicrobial specification
View Source
FDA Device Recall: Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm
2015-07-08
Class II — Catheters may not meet antimicrobial specification
View Source
FDA Device Recall: Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item Code:
2015-07-08
Class II — Catheters may not meet antimicrobial specification
View Source
FDA Device Recall: Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code:8
2015-07-08
Class II — Catheters may not meet antimicrobial specification
View Source
FDA Device Recall: Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm I
2015-07-08
Class II — Catheters may not meet antimicrobial specification
View Source
FDA Device Recall: Palindrome SI Chronic Catheter Kit 14.5 Fr x 55cm Item Code: 8888145066
2015-07-08
Class II — Catheters may not meet antimicrobial specification
View Source
FDA Device Recall: Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code:
2015-07-08
Class II — Catheters may not meet antimicrobial specification
View Source
FDA Device Recall: Palindrome SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm Item
2015-07-08
Class II — Catheters may not meet antimicrobial specification
View Source
FDA Device Recall: Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm
2015-07-08
Class II — Catheters may not meet antimicrobial specification
View Source
FDA Device Recall: Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item Code
2015-07-08
Class II — Catheters may not meet antimicrobial specification
View Source
FDA Device Recall: Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm I
2015-07-08
Class II — Catheters may not meet antimicrobial specification
View Source
FDA Device Recall: Palindrome SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 23cm Item
2015-07-08
Class II — Catheters may not meet antimicrobial specification
View Source
FDA Device Recall: Palindrome Precision HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x
2015-07-08
Class II — Catheters may not meet antimicrobial specification
View Source
FDA Device Recall: Palindrome SI Chronic Catheter Kit 14.5 Fr x 28cm Item Code: 8888245064
2015-07-08
Class II — Catheters may not meet antimicrobial specification
View Source
FDA Device Recall: VenaSeal, Sapheon Closure System, Model # SP-101, VS-301 and VS-402. For vascula
2015-05-20
Class II — Possible sterility breach of the outer packaging (pouch) material which may compromise the outside surface sterility of the sealed inner tray.
View Source
FDA Device Recall: Covidien Trellis-8 Peripheral Infusion System. Models CVT808015, CVT808025, CVT
2015-02-11
Class I — A manufacturing error resulted in the risk of incorrect proximal and distal balloon inflation port identification on the units. Units have been identified to have the distal balloon inflati...
View Source
FDA Recall: Covidien LLC — Class I
20141022
Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model FR3 or FRx AEDs | Product: Coviden Medi-Trace Cadence Adult Multi-Function Defibrillation El...
View Source
FDA Device Recall: Coviden Medi-Trace Cadence Adult Multi-Function Defibrillation Electrodes, Pre-c
2014-10-22
Class I — Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model FR3 or FRx AEDs
View Source
FDA Device Recall: Covidien Medi-Trace Cadence and Kendall Adult Multi-Function Defibrillation Elec
2014-10-22
Class I — Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model FR3 or FRx AEDs Defibrillators
View Source
FDA Device Recall: Covidien Kendall 1710H Multi-Function Defibrillation Electrodes Part Number: 40
2014-10-22
Class I — Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model FR3 or FRx AEDs
View Source
FDA Device Recall: MediChoice¿ Multifunction Electrode Part Number: MC171 OH
2014-10-22
Class I — Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model FR3 or FRx AEDs
View Source
FDA Device Recall: Philips HEARTSTART Multifunction Electrode Pads Part Number: M3718A
2014-10-22
Class I — Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model FR3 or FRx AEDs
View Source
FDA Recall: Covidien LLC — Class II
20130918
Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin | Product: Monoject 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 3 mL Fill Product ID: 8881580123 ...
View Source
FDA Recall: Covidien LLC — Class II
20130918
Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin | Product: Monoject 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 10 mL Fill Product ID: 888157...
View Source
FDA Recall: Covidien LP — Class II
20130612
Seals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity | Product: Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Long ...
View Source
FDA Device Recall: Monoject 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 3 mL Fill Product I
2013-09-18
Class II — Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin
View Source
FDA Device Recall: Monoject 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 10 mL Fill Prod
2013-09-18
Class II — Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin
View Source
FDA Device Recall: Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 5 mL Fill Product
2013-09-18
Class II — Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin
View Source
FDA Device Recall: Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 3 mL Fill Product
2013-09-18
Class II — Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin
View Source
FDA Device Recall: Monoject 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 5 mL Fill Product I
2013-09-18
Class II — Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin
View Source
FDA Device Recall: Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 10 mL Fill Product
2013-09-18
Class II — Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin
View Source
FDA Device Recall: Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Long Product Co
2013-06-12
Class II — Seals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity
View Source
FDA Device Recall: Versaport Bladeless Optical Trocar With (2) Fixation Cannulae - 5mm Product C
2013-06-12
Class II — Seals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity
View Source
FDA Device Recall: Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Short Product
2013-06-12
Class II — Seals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity
View Source
FDA Device Recall: Versaport Bladeless Optical Fixation Cannula - 5mm Short Product Code: ONBFCA
2013-06-12
Class II — Seals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity
View Source
FDA Device Recall: Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Product Code: ON
2013-06-12
Class II — Seals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity
View Source
FDA Device Recall: Medi-Trace Cadence Pediatric Radiotransparent Defibrillation Electrode Product
2013-05-08
Class II — Defibrillation Electrodes may arc/spark result in thermal damage to the leadwire, which could render the device incapable of delivering the appropriate energy or shock to the patient
View Source
FDA Recall: Covidien LP — Class II
20121003
Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications. | Product: Covidien Duet TRS 60 4.8 mm Universal Articulati...
View Source
FDA Recall: Covidien LP — Class II
20121003
Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications | Product: Covidien Duet TRS 60 3.5 mm Universal Articulating...
View Source
FDA Recall: Covidien LP — Class II
20121003
Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications | Product: Covidien Duet TRS 45 3.5 mm Universal Straight Sin...
View Source
FDA Device Recall: Covidien Duet TRS 60 4.8 mm Universal Articulating Single Use Loading Unit. Pro
2012-10-03
Class II — Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications.
View Source
FDA Device Recall: Covidien Duet TRS 60 3.5 mm Universal Articulating Single Use Loading Unit. Pro
2012-10-03
Class II — Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications
View Source
FDA Device Recall: Covidien Duet TRS 45 3.5 mm Universal Straight Single Use Loading Unit. Product
2012-10-03
Class II — Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications
View Source
FDA Device Recall: Covidien Duet TRS 45 3.5 mm Universal Articulating Single Use Loading Unit. Pro
2012-10-03
Class II — Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications.
View Source
FDA Device Recall: Covidien Duet TRS 45 4.8 mm Universal Articulating Single Use Loading Unit. Pro
2012-10-03
Class II — Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications
View Source
FDA Device Recall: Covidien Duet TRS 60 3.5 mm Universal Straight Single Use Loading Unit Product
2012-10-03
Class II — Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications
View Source
FDA Device Recall: HALO Flex Energy Generators Manufactured by B¿RRX Medical (now Covidien) 540
2012-09-26
Class II — Potential failure of HALO Energy Generator to enter "stand by" mode when initially powered on; and therefore can not be used for patient care.
View Source
FDA Device Recall: Covidien ROTICULATOR 55-4.8 Single Use Stapler REF# 017614 The RETICULA TOR
2012-06-27
Class II — Potential for the sterility barrier to be compromised.
View Source
FDA Device Recall: Covidien ROTICULATOR 55-3.5 Single Use Stapler REF# 017612 The RETICULA TOR
2012-06-27
Class II — Potential for the sterility barrier to be compromised.
View Source
lobbying
1 records
Lobbying Firm: COVIDIEN LP
Registered lobbying firm — Washington, DC — Medical Products Manufacturer
View Source
ny_corps
1 records
NY Corp: COVIDIEN LP
1998-10-22
FOREIGN LIMITED PARTNERSHIP | County: New York | Jurisdiction: Delaware
View Source
ny_spills
3 records
NY Spill: COVIDIEN — transformer oil
2012-06-11
WATERTOWN, Jefferson County | 0.00 Gallons of transformer oil
NY Spill: COVIDIEN — transformer oil
2012-06-11
WATERTOWN, Jefferson County | 0.00 Gallons of transformer oil
NY Spill: COVIDIEN — transformer oil
2012-06-11
WATERTOWN, Jefferson County | 0.00 Gallons of transformer oil
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