Browse Device Recalls

252 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 252 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 252 FDA device recalls.

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DateProductReasonClassFirm
Jul 27, 2011 Access Immunoassay Systems Total T4 Calibrators, Part Number: 33805. The... A recall communication was initiated because Beckman has identified that Access Total T4 calibrat... Class II Beckman Coulter Inc.
Sep 22, 2010 ISE Electrolyte Reference reagent (for Synchron LX Systems and UniCel DxC 600... Beckman Coulter is recalling the Synchron Systems LX20/UniCel DxC ISE Reference Reagent because i... Class II Beckman Coulter 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.