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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
Mar 23, 2017 Sysmex, Automated Hematology Analyzer XN Series, Sysmex Corporation, 1-5-1 Wa... Reported customer complaints of automated hematology analyzers catching fire due to misalignment ... Class II Sysmex America Inc
Jul 1, 2016 Fluorocell PLT reagent, Catalog #CD994563 Fluorocell PLT is used to stain pl... There is a potential that fluorescent platelet (PLT-F) and immature platelet fraction (IPF%) resu... Class II Sysmex America Inc
May 15, 2013 pocH-100i; sysmex; Automated Hematology Analyzer; 7.3" x 13.8" x 18.1" / 30.8... The data printed on the thermal printer may omit a digit or decimal point in the results or sampl... Class II Sysmex America 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.