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Browse Device Recalls

7 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 7 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 7 FDA device recalls.

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DateProductReasonClassFirm
Dec 31, 2025 Medica Capillary Tubes; EasyBloodGas/EasyStat Capillary Tube Kit. A systematic positive bias of up to 20% was identified across the reportable potassium range, res... Class II Medica Corporation
Feb 6, 2019 Medica Wash1-Wash solution used prior to Lipase assay on the EasyRA clinical ... Wash1 solution is ineffective in cleaning dispensing probe of TRIG and LDL reagents that interfer... Class II Medica Corporation
May 9, 2018 OptiMedica Catalys Precision Laser System, CE 0044 containing software cOS 5.... Software upgrade exhibits failures when executing Daily Alignment Verification (DAV), specificall... Class II Johnson & Johnson Surgical Vision Inc
Nov 21, 2017 Wash Kit (REF 10680) Lots 16279, 17045 and 17215 Medica corporation is mar... The firm has initiated a field recall of the Wash1 Kit REF 10680 due to reported inconsistent Li... Class II Medica Corporation
Apr 11, 2017 EasyCAL HbA1c Calibrator; REF 10658 Kit is packaged in a paper box containin... Patient results determined using this calibrator lot might deviate up to 20%. Controls might not ... Class II Medica Corporation
Feb 20, 2015 Catalys Precision Laser System-Catalys - U - US product; Catalys-1 - Internat... Software anomaly on OptiMedica CATALYS System version 3.00.05 that may result in incorrect parame... Class II Optimedica Corporation
Dec 20, 2013 Catalys Precision Laser System (United States) - Catalys-U: Catalys Precisio... Potential for unexpected heating of the transformer mounting bolt located within the system chass... Class II Optimedica Corporation

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.