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Browse Device Recalls

5 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5 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 5 FDA device recalls.

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DateProductReasonClassFirm
May 12, 2025 The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue G... Glucose microcuvettes experienced transit time outside of limits, so stability through the whole ... Class II HemoCue AB
Jul 25, 2013 HemoCue¿ Hb 201 Microcuvettes, carton/4 boxes/25 pouches of Microcuvettes, He... HemoCue AB has become aware of a production related problem involving punctured HemoCue Hb 201 Mi... Class II HemoCue AB
Jul 16, 2013 HemoCue¿ Urine Albumin Microcuvettes, 25 Microcuvettes HemoCue AB Angelholm, ... HemoCue AB has become aware of a production related problem involving punctured HemoCue¿ Urine Al... Class II HemoCue AB
Jul 15, 2013 HemoCue¿ Glucose 201 Microcuvettes, 25 Microcuvettes Individually Packaged. ... During a complaint investigation HemoCue AB discovered punctured HemoCue Glucose 201 single pack ... Class II HemoCue AB
Nov 7, 2012 Analyzing system consists of a small and portable analyzer and plastic microc... Incorrect version of Quick Reference Guide (QRG) was delivered with products in shipment made fro... Class III HemoCue AB

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.