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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
Feb 29, 2016 Medica ISE Module Calibrant A; 500 mL - 140 mmol/L Na+, 125 mmol/L Cl-, buffe... Lot was not functioning properly and not exhibiting the correct physical properties. Class III AMS Diagnostics, LLC
Feb 11, 2014 AMS BUN UREA NITROGEN For the In vitro quantitative determination of Urea Nit... Marketing the devices outside 510(k) requirements Class II AMS Diagnostics, LLC
Feb 11, 2014 AMS AST For the In vitro quantitative determination of AST in serum Quant... Marketing the devices outside 510(k) requirements Class II AMS Diagnostics, LLC
Feb 11, 2014 AMS URIC ACID For the In vitro quantitative determination of Uric Acid in ser... Marketing the devices outside 510(k) requirements Class II AMS Diagnostics, 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.