Browse Device Recalls
53 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 53 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 53 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 18, 2025 | Zenith Alpha 2 Thoracic Endovascular Graft, Catalog Prefix ZTA2- Reference... | Affected devices may contain PTFE coating scrapings. Scrapings could be released during device de... | Class I | Cook Medical Incorporated |
| Apr 1, 2024 | EchoTip¿ Ultra Endoscopic Ultrasound Access Needle, ECHO-19, G31520 | Devices may contain elevated levels of bacterial endotoxin. | Class II | Cook Medical Incorporated |
| Apr 1, 2024 | EchoTip¿ Ultra HD Endoscopic Ultrasound Access Needle, ECHO-HD-19-A, G52012 | Devices may contain elevated levels of bacterial endotoxin. | Class II | Cook Medical Incorporated |
| Feb 14, 2022 | Cook Celect PlatinumVena Cava Filter Set Catalog Number/GPN: IGTCFS-65-1-F... | IFU update includes an update to the Device description, Intended Use/Indications for Use, Contr... | Class III | Cook Medical Incorporated |
| Feb 14, 2022 | Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach Catalog Number/... | IFU update includes an update to the Device description, Intended Use/Indications for Use, Contr... | Class III | Cook Medical Incorporated |
| Feb 25, 2019 | Gunther Tulip Vena Cava Filter Set for Jugular Vein Approach, Catalog Number... | Updates to the Instructions for Use. | Class III | Cook Medical Incorporated |
| Feb 25, 2019 | Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Catalog... | Updates to the Instructions for Use. | Class III | Cook Medical Incorporated |
| Feb 25, 2019 | Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Catalog Number... | Updates to the Instructions for Use. | Class III | Cook Medical Incorporated |
| Feb 25, 2019 | Gunther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach, Ca... | Updates to the Instructions for Use. | Class III | Cook Medical Incorporated |
| Feb 25, 2019 | Cook Celect Platinum Vena Cava Filter Set for Jugular Vein Approach, Catalog... | Updates to the Instructions for Use. | Class III | Cook Medical Incorporated |
| Feb 25, 2019 | Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Appro... | Updates to the Instructions for Use. | Class III | Cook Medical Incorporated |
| Sep 25, 2018 | Zilver 635 Biliary Stent 4mm x 80mm, Catalog Number: ZIB6-80-4.0-80 Prod... | The instruction for use detail, with respect to removal of the delivery system as part of Deploym... | Class II | Cook Medical Incorporated |
| Sep 25, 2018 | Zilver 635 Biliary Stent 5mm x 40mm, Catalog Number: ZIB6-125-5.0-40 Pro... | The instruction for use detail, with respect to removal of the delivery system as part of Deploym... | Class II | Cook Medical Incorporated |
| Sep 25, 2018 | Zilver 635 Biliary Stent 5mm x 40mm, Catalog Number: ZIB6-80-5.0-40 Prod... | The instruction for use detail, with respect to removal of the delivery system as part of Deploym... | Class II | Cook Medical Incorporated |
| Sep 25, 2018 | Zilver 518 Biliary Stent 4mm x 30mm, Catalog Number: ZIB5-125-4.0-30 Pro... | The instruction for use detail, with respect to removal of the delivery system as part of Deploym... | Class II | Cook Medical Incorporated |
| Sep 25, 2018 | Zilver Biliary 518 Stent 5mm x 60mm, Catalog Number: ZIB5-125-5.0-60 Pr... | The instruction for use detail, with respect to removal of the delivery system as part of Deploym... | Class II | Cook Medical Incorporated |
| Sep 25, 2018 | Zilver 635 Biliary Stent 5mm x 60mm, Catalog Number: ZIB6-80-5.0-60 Prod... | The instruction for use detail, with respect to removal of the delivery system as part of Deploym... | Class II | Cook Medical Incorporated |
| Sep 25, 2018 | Zilver 635 Biliary Stent 12mm x 60mm, Catalog Number: ZIB6-125-12.0-60 P... | The instruction for use detail, with respect to removal of the delivery system as part of Deploym... | Class II | Cook Medical Incorporated |
| Sep 25, 2018 | Zilver 635 Biliary Stent 14mm x 60mm, Catalog Number: ZIB6-80-14.0-60 Pr... | The instruction for use detail, with respect to removal of the delivery system as part of Deploym... | Class II | Cook Medical Incorporated |
| Sep 25, 2018 | Zilver 635 Biliary Stent 12mm x 30mm, Catalog Number: ZIB6-125-12.0-30 P... | The instruction for use detail, with respect to removal of the delivery system as part of Deploym... | Class II | Cook Medical Incorporated |
| Sep 25, 2018 | Zilver 635 Biliary Stent 14mm x 80mm, Catalog Number: ZIB6-80-14.0-80 Pr... | The instruction for use detail, with respect to removal of the delivery system as part of Deploym... | Class II | Cook Medical Incorporated |
| Sep 25, 2018 | Zilver 635 Biliary Stent 4mm x 80mm, Catalog Number: ZIB6-125-4.0-80 Pro... | The instruction for use detail, with respect to removal of the delivery system as part of Deploym... | Class II | Cook Medical Incorporated |
| Sep 25, 2018 | Zilver 518 Biliary Stent 5mm x 40mm, Catalog Number: ZIB5-125-5.0-40 Pro... | The instruction for use detail, with respect to removal of the delivery system as part of Deploym... | Class II | Cook Medical Incorporated |
| Sep 25, 2018 | Zilver 635 Biliary Stent 12mm x 80mm, Catalog Number: ZIB6-125-12.0-80 P... | The instruction for use detail, with respect to removal of the delivery system as part of Deploym... | Class II | Cook Medical Incorporated |
| Sep 25, 2018 | Zilver 518 Biliary Stent 5mm x 20mm, Catalog Number: ZIB5-125-5.0-20 Pro... | The instruction for use detail, with respect to removal of the delivery system as part of Deploym... | Class II | Cook Medical Incorporated |
| Sep 25, 2018 | Zilver 518 Biliary Stent 4mm x 60mm, Catalog Number: ZIB5-125-4.0-60 Pro... | The instruction for use detail, with respect to removal of the delivery system as part of Deploym... | Class II | Cook Medical Incorporated |
| Sep 25, 2018 | Zilver 518 Biliary Stent 5mm x 80mm, Catalog Number: ZIB5-80-5.0-80 Prod... | The instruction for use detail, with respect to removal of the delivery system as part of Deploym... | Class II | Cook Medical Incorporated |
| Sep 25, 2018 | Zilver 635 Biliary Stent 12mm x 40mm, Catalog Number: ZIB6-125-12.0-40 P... | The instruction for use detail, with respect to removal of the delivery system as part of Deploym... | Class II | Cook Medical Incorporated |
| Sep 25, 2018 | Zilver 635 Biliary Stent 12mm x 40mm, Catalog Number: ZIB6-80-12.0-40 Pr... | The instruction for use detail, with respect to removal of the delivery system as part of Deploym... | Class II | Cook Medical Incorporated |
| Sep 25, 2018 | Zilver 635 Biliary Stent 5mm x 80mm, Catalog Number: ZIB6-80-5.0-80 Prod... | The instruction for use detail, with respect to removal of the delivery system as part of Deploym... | Class II | Cook Medical Incorporated |
| Sep 25, 2018 | Zilver 518 Biliary Stent 4mm x 80mm, Catalog Number: ZIB5-125-4.0-80 Pro... | The instruction for use detail, with respect to removal of the delivery system as part of Deploym... | Class II | Cook Medical Incorporated |
| Sep 25, 2018 | Zilver 635 Biliary Stent 14mm x 40mm, Catalog Number: ZIB6-80-14.0-40 Pr... | The instruction for use detail, with respect to removal of the delivery system as part of Deploym... | Class II | Cook Medical Incorporated |
| Sep 25, 2018 | Zilver 635 Biliary Stent 5mm x 80mm, Catalog Number: ZIB6-125-5.0-80 Pro... | The instruction for use detail, with respect to removal of the delivery system as part of Deploym... | Class II | Cook Medical Incorporated |
| Sep 25, 2018 | Zilver 518 Biliary Stent 4mm x 20mm, Catalog Number: ZIB5-125-4.0-20 Produ... | The instruction for use detail, with respect to removal of the delivery system as part of Deploym... | Class II | Cook Medical Incorporated |
| Sep 25, 2018 | Zilver 635 Biliary Stent 5mm x 20mm, Catalog Number: ZIB6-125-5.0-20 Pro... | The instruction for use detail, with respect to removal of the delivery system as part of Deploym... | Class II | Cook Medical Incorporated |
| Sep 25, 2018 | Zilver 518 Biliary Stent 4mm x 40mm, Catalog Number: ZIB5-125-4.0-40 Pro... | The instruction for use detail, with respect to removal of the delivery system as part of Deploym... | Class II | Cook Medical Incorporated |
| Sep 25, 2018 | Zilver 635 Biliary Stent 12mm x 30mm, Catalog Number: ZIB6-80-12.0-30 Pr... | The instruction for use detail, with respect to removal of the delivery system as part of Deploym... | Class II | Cook Medical Incorporated |
| Sep 25, 2018 | Zilver 635 Biliary Stent 12mm x 80mm, Catalog Number: ZIB6-80-12.0-80 Pr... | The instruction for use detail, with respect to removal of the delivery system as part of Deploym... | Class II | Cook Medical Incorporated |
| Sep 25, 2018 | Zilver 635 Biliary Stent 14mm x 30mm, Catalog Number: ZIB6-125-14.0-30 P... | The instruction for use detail, with respect to removal of the delivery system as part of Deploym... | Class II | Cook Medical Incorporated |
| Sep 25, 2018 | Zilver 518 Biliary Stent 5mm x 80mm, Catalog Number: ZIB5-125-5.0-80 Pro... | The instruction for use detail, with respect to removal of the delivery system as part of Deploym... | Class II | Cook Medical Incorporated |
| Sep 25, 2018 | Zilver 635 Biliary Stent 14mm x 40mm, Catalog Number: ZIB6-125-14.0-40 P... | The instruction for use detail, with respect to removal of the delivery system as part of Deploym... | Class II | Cook Medical Incorporated |
| Sep 25, 2018 | Zilver 635 Biliary Stent 5mm x 20mm, Catalog Number: ZIB6-80-5.0-20 Prod... | The instruction for use detail, with respect to removal of the delivery system as part of Deploym... | Class II | Cook Medical Incorporated |
| Sep 25, 2018 | Zilver 635 Biliary Stent 5mm x 30mm, Catalog Number: ZIB6-125-5.0-30 Pro... | The instruction for use detail, with respect to removal of the delivery system as part of Deploym... | Class II | Cook Medical Incorporated |
| Sep 25, 2018 | Zilver 635 Biliary Stent 5mm x 60mm, Catalog Number: ZIB6-125-5.0-60 Pro... | The instruction for use detail, with respect to removal of the delivery system as part of Deploym... | Class II | Cook Medical Incorporated |
| Sep 25, 2018 | Zilver 635 Biliary Stent 14mm x 60mm, Catalog Number: ZIB6-125-14.0-60 P... | The instruction for use detail, with respect to removal of the delivery system as part of Deploym... | Class II | Cook Medical Incorporated |
| Sep 25, 2018 | Zilver 635 Biliary Stent 14mm x 80mm, Catalog Number: ZIB6-125-14.0-80 P... | The instruction for use detail, with respect to removal of the delivery system as part of Deploym... | Class II | Cook Medical Incorporated |
| Sep 25, 2018 | Zilver 635 Biliary Stent 12mm x 60mm, Catalog Number: ZIB6-80-12.0-60 Pr... | The instruction for use detail, with respect to removal of the delivery system as part of Deploym... | Class II | Cook Medical Incorporated |
| Sep 25, 2018 | Zilver 635 Biliary Stent 5mm x 30mm, Catalog Number: ZIB6-80-5.0-30 Prod... | The instruction for use detail, with respect to removal of the delivery system as part of Deploym... | Class II | Cook Medical Incorporated |
| Sep 25, 2018 | Zilver 518 Biliary Stent 5mm x 30mm, Catalog Number: ZIB5-125-5.0-30 Pro... | The instruction for use detail, with respect to removal of the delivery system as part of Deploym... | Class II | Cook Medical Incorporated |
| Sep 25, 2018 | Zilver 635 Biliary Stent 14mm x 30mm, Catalog Number: ZIB6-80-14.0-30 Pr... | The instruction for use detail, with respect to removal of the delivery system as part of Deploym... | Class II | Cook Medical Incorporated |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.