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Browse Device Recalls

2 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2 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 2 FDA device recalls.

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DateProductReasonClassFirm
Mar 11, 2024 OsmoPRO MAX Automated Osmometer- IVD Osmometer for Clinical Use. Uses the met... System error messages may delay the ability to test patient samples and the need for frequent cal... Class II Advanced Instruments, LLC
Feb 7, 2018 GloCyte RBC Reagent - Product Usage: The GloCyte Automated Cell Counter Syste... RBC Reagent failure. High fluorescent counts during RBC Reagent + Diluent QC check that will resu... Class II Advanced Instruments, LLC

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.