Browse Device Recalls
3 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3 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 3 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 5, 2016 | Accessory Adapter Part number 600525A0 Product Usage: designed for the mo... | Maquet Inc. is initiating a voluntary field action on the Accessory Adapter part number 600525A0 ... | Class II | Maquet Medical Systems USA |
| Nov 2, 2012 | Maquet Yuno Extension Table Device Maquet GmbH & Co. KG Kehler Strabe 31 B... | There is a potential issue with the screw tension of the extension device 1433.62A1 used with the... | Class II | Maquet Inc. |
| May 29, 2012 | Maquet Getinge Group Pediatric Arterial Cannula Maquet Cardiopulmonary AG K... | Certain pediatric arterial cannulas may have limited flexibility due to an increased length of th... | Class II | Maquet Inc. |
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.