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Browse Device Recalls

5 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5 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 5 FDA device recalls.

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DateProductReasonClassFirm
May 15, 2015 PROcise XP Wand with Integrated Cable REF EICA8872-01 Product Usage: PLAS... Potential component failure resulting in inoperability Class II ArthroCare Medical Corporation
May 15, 2015 EVAC 70 XTRA with Integrated Cable REF EICA5872-01 Product Usage: PLASMA ... Potential component failure causing device inoperability Class II ArthroCare Medical Corporation
Feb 20, 2015 Coblator II System, 120V. Product Usage: The Coblator II (Model RF8000E)... The recalling firm was notified by the contract manufacturer that they had reversed the L2, L3, L... Class II ArthroCare Medical Corporation
Oct 27, 2014 Model Number ASHA4730-01: Ambient HipVac 50 Wand with Integrated Finger Switc... Potential breach of sterile barrier due to defective product tray. Class II ArthroCare Medical Corporation
Dec 9, 2013 Arthrocare SPORTS MEDICINE, Knot Pusher, REF 25-3011, LOT #1049402, CON 1, 20... A sharp edge on the cannulated tip of the device may damage or cut a suture. Class II ArthroCare Medical Corporation

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.