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Browse Device Recalls

3 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3 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 3 FDA device recalls.

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DateProductReasonClassFirm
Sep 16, 2015 BG cartridges for IRMA TRUPOINT Blood Gas Analyzer, PN 048103. BG Cartrid... May report values outside the published performance specifications for pH. After a certain point... Class II LifeHealth, LLC
Sep 16, 2015 CC cartridges for IRMA TRUPOINT Blood Gas Analyzer, PN 039903. The CC Cartri... May report values outside the published performance specifications for pH. After a certain point... Class II LifeHealth, LLC
Apr 29, 2015 LifeHealth, IRMA TRUPOINT model 443914, typically used in point-of-care setti... The barometric pressure measurement output of this particular IRMA TRUPoint SN 443914 device will... Class II LifeHealth, 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.