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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
Feb 8, 2017 AIA-PACK TgAb CONTROL SET The label contains two different methodologies. Quality Control values for non-FDA approved metho... Class III Tosoh Bioscience, Inc.
Feb 8, 2017 AIA-PACK TPOAb CONTROL SET The label contains two different methodologies. Quality Control values for non-FDA approved metho... Class III Tosoh Bioscience, Inc.
Nov 7, 2016 Tosoh Bioscience HLC-723G8 Analyzer for HbA1c testing. The device defect associated with this recall may result in HbA1c values with a negative bias in ... Class II Tosoh Bioscience, Inc.
Jun 7, 2016 Instructions for Use (IFU) for Progesterone 3 Calibrator Set, repackaged as o... Instructions For Use had incorrect lot number and calibrator values Class III Tosoh Bioscience, Inc.
Feb 10, 2015 G7 Variant Elution Buffer HiS no. 1 (M) component of the Tosoh Automated Glyc... The G7 Variant Elution Buffer HiS no. 1 (M) is incorrectly labeled with an expiration date of Oct... Class III Tosoh Bioscience, 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.