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Browse Device Recalls

8 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 8 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 8 FDA device recalls.

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DateProductReasonClassFirm
Jun 17, 2022 Merlin.net model MN5000 Software The Merlin" 2 PCS model MER3700 is a portable, dedicated programming system designed to interrog... Class II St. Jude Medical, Cardiac Rhythm Management Div...
Jun 17, 2022 Merlin PCS 3650 programmer Model 3330 software There is a potential for programmer software (Merlin PCS) and remote monitoring software applicat... Class II St. Jude Medical, Cardiac Rhythm Management Div...
Jun 17, 2022 Merlin 2 PCS MER37000 programmer Model MER3400 software The Merlin" 2 PCS model MER3700 is a portable, dedicated programming system designed to interrog... Class II St. Jude Medical, Cardiac Rhythm Management Div...
Mar 10, 2022 Gallant VR Implantable Cardioverter Defibrillator REF # CDVRA500Q Bluetooth malfunction impacting Gallant devices post-implant. The failure causes the device to e... Class II St. Jude Medical, Cardiac Rhythm Management Div...
Mar 10, 2022 Merlin PCS 3650 programmer Model 3330 software Due to a programmer software anomaly under very specific circumstance when executing a pacing cap... Class II St. Jude Medical, Cardiac Rhythm Management Div...
Mar 10, 2022 Merlin 2 PCS MER3700 programmer Model MER3400 software Due to a programmer software anomaly under very specific circumstance when executing a pacing cap... Class II St. Jude Medical, Cardiac Rhythm Management Div...
Mar 10, 2022 Gallant DR Implantable Cardioverter Defibrillator REF # CDDRA500Q Bluetooth malfunction impacting Gallant devices post-implant. The failure causes the device to e... Class II St. Jude Medical, Cardiac Rhythm Management Div...
Mar 10, 2022 Gallant HF Implantable Cardioverter Defibrillator REF# CDHFA500Q Bluetooth malfunction impacting Gallant devices post-implant. The failure causes the device to e... Class II St. Jude Medical, Cardiac Rhythm Management Div...

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.