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Browse Device Recalls

53 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 53 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 53 FDA device recalls.

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DateProductReasonClassFirm
Mar 22, 2017 Zenith Alpha Thoracic Endovascular Graft The Zenith Alpha" Thoracic Endova... There have been five reports of graft thrombosis/occlusion during global commercial use, each fo... Class I Cook Medical Incorporated
Dec 22, 2015 Zilver¿ 518RX Vascular Stent with Rapid Exchange Delivery System Manufacturing of the joint between the inner catheter and stylet of the delivery system does not ... Class II Cook Medical Incorporated
Sep 26, 2014 Spirotome" Soft-Tissue Biopsy Needle Set. The Spirotome Biopsy Needle Set ... MEDINVENTS, the manufacturer of the Spirotome" Soft-Tissue Biopsy Needle Set distributed by ... Class II Cook Medical Incorporated

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.