Browse Device Recalls

4 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 4 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 4 FDA device recalls.

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DateProductReasonClassFirm
Jun 10, 2026 Abiomed REF: 0052-3006, Introducer Kit for Impella Hemostatic Peel Away Int... Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to lea... Class I Oscor Inc.
Jun 10, 2026 Abiomed REF: 0052-3021, Introducer Kit for Impella Hemostatic Peel Away Int... Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to lea... Class I Oscor Inc.
Jun 10, 2026 Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Int... Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to lea... Class I Oscor Inc.
Dec 22, 2021 Destino Twist 14F (also branded as Guidestar 14F) There is potential for separation between the threaded hub and threaded cap at the proximal end o... Class II Oscor 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.