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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 23, 2016 EV3 EverFiex" Self-expanding Peripheral Stent System, Sterilized using Ethyl... Medtronic is issuing a medical device recall to return product potentially associated with an out... Class II Ev3, Inc.
Mar 29, 2016 ev3, PowerCross" 0.018" OTW PTA Dilatation Catheter, model: AB18W030200150, S... Medtronic is conducting a voluntary Urgent Medical Device Recall of two lots of the PowerCross 0.... Class II ev3, Inc.
Dec 4, 2014 ev3 Protege Rx Tapered Carotid Stent System, SECX-10-7-40-135, Sterile EO, R... Two production lots of the Protege Rx Tapered Carotid Stent Systems (SECX-10-7-40-135, Lot # 9922... Class II Ev3, Inc.
Dec 4, 2014 ev3, Prot¿g¿ Rx Tapered Carotid Stent System, SEPX-8-6-40-135, Sterile EO, R... Two production lots of the Protege Rx Tapered Carotid Stent Systems (SECX-10-7-40-135, Lot # 9922... Class II Ev3, Inc.
Apr 9, 2014 ev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 120mm x 135cm, REF:... Covidien is recalling 2 production lots of EverCross 0.035 PTA Balloon Catheter because of a prod... Class II Ev3, 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.