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Browse Device Recalls

7 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 7 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 7 FDA device recalls.

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DateProductReasonClassFirm
Apr 30, 2025 Cardiohelp System HKH 8820 Wall Holder. Mounting bracket designed to hold the... HKH 8820 Wall Holder does not comply with standard DIN EN 1789:20 and has the potential to detach. Class II Maquet Cardiopulmonary Ag
May 14, 2018 Aortic Arterial Cannula 24 Fr (O.D.); 23 cm (L); with 3/8-inch connector with... This lot of arterial cannula may have been supplied with 3/8-width de-airing plugs that could bre... Class II Maquet Cardiopulmonary Ag
May 14, 2018 Aortic Arterial Cannula 20 Fr (O.D.); 23 cm (L); with 3/8-inch wide connector... This lot of arterial cannula may have been supplied with 3/8-width de-airing plugs that could bre... Class II Maquet Cardiopulmonary Ag
May 14, 2018 Aortic Arterial Cannula 22 Fr (O.D.); 23 cm (L); with 3/8-inch connector with... This lot of arterial cannula may have been supplied with 3/8-width de-airing plugs that could bre... Class II Maquet Cardiopulmonary Ag
Apr 4, 2018 CARDIOHELP Gas Bottle Holder HKH 8880, Product Code/Part Number 70105.0901 ... There is a possibility for the clamps of the gas bottle holder to crack or break when exposed to ... Class II Maquet Cardiopulmonary Ag
Sep 12, 2013 MAQUET Getinge Group CARDIOHELP Base Unit REF 70104.7999 REF 70104.8012 Manuf... It has come to the attention of MAQUET that in certain rare instances, the CARDIOHELP-i device ma... Class II Maquet Medical Systems USA
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.