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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
Nov 3, 2015 Optisure Dual Coil Defibrillation Leads, Model No. LDA220, LDA220Q, LDA230Q, ... Leads may have been compromised during the manufacturing process, with cuts in the insulation lay... Class I St Jude Medical Cardiac Rhythm Management Division
Aug 18, 2015 Merlin@home RF Remote Monitoring Transmitter Model EX1150. Intended to aid... Some devices exhibit backup VVI operation due to a backup reset. Class II St Jude Medical Cardiac Rhythm Management Division
Dec 18, 2014 Merlin@home RF Remote Monitoring Transmitter, Model EX1150, with software ver... Transmitter may initiate a software reset resulting in backup operation in some implanted St. Jud... Class II St Jude Medical Cardiac Rhythm Management Division
Aug 19, 2014 Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD... An anomaly may result in delayed, partial, or no delivery of high voltage therapy. Internal damag... Class II St Jude Medical Cardiac Rhythm Management Division

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.