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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
Mar 19, 2025 Brand Name: Quantum Informatics - VISION / LIVE VUE Product Name: Monitor, P... Medical device software marketed without FDA clearance . Class II Spectrum Medical Ltd.
Mar 19, 2025 Brand Name: Quantum Informatics - VIPER Product Name: Monitor, Physiological... Medical device software marketed without FDA clearance . Class II Spectrum Medical Ltd.
Mar 13, 2023 Quantum Perfusion Systems for CPB, Roller Pumps use peristaltic action to pro... The ratchet and pawl had an out of tolerance geometry which exhibited as the left bobbin would no... Class II Spectrum Medical Ltd.
May 29, 2019 Quantum Pump Console Potential for Quantum Pump Console, part of the Quantum Perfusion Systems, to unexpectedly shut d... Class I Spectrum Medical Ltd.

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.