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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
Apr 21, 2017 Drew Scientific DREW 3-PAC Reagent Kit containing: 5L Diluent, 750 mL Enzymat... May result in elevated platelet backgrounds during routine startup/background checks. Class II JAS Diagnostics Inc.
Oct 23, 2014 Glucose Hexokinase (Liquid) Reagent For the in vitro quantitative determin... Product is not performing according to specifications. Control 2 does not consistently recover wi... Class II JAS Diagnostics Inc.
Apr 7, 2014 Glucose Hexokinase Liquid Reagent For the in vitro quantitative determination... JAS Diagnostics, Inc. of Miami Lakes, FL is recalling their Glucose Hexokinase reagent due to cer... Class II JAS Diagnostics Inc.

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.