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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.

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DateProductReasonClassFirm
May 22, 2024 2nd Generation CentriMag Primary Console, REF: 201-90401, 201-90701, 201-9041... Due to a component change, the console part of a circulatory support system may not conform to th... Class II Thoratec Switzerland GMBH
Aug 22, 2019 CentriMag Acute Circulatory Support System Motor, U.S. Model 102956 and OUS M... Reports have been received of the CentriMag Systems experiencing motor and pump issues resulting ... Class I Thoratec Switzerland GMBH
Sep 5, 2018 Thoratec CentriMag Motor, Model: 102956, a component of the Thoratec CentriMa... Reports of circulatory support system motor stopping. Motor stop can be attributed to a break of ... Class II Thoratec Switzerland GMBH

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.