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Browse Device Recalls

4 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 4 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 4 FDA device recalls.

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DateProductReasonClassFirm
Oct 23, 2019 Alinity c Carbon Dioxide Reagent Kit, Produced for Abbott by Sekisui Diagnos... Abbott internal studies have determined that atmospheric Carbon Dioxide (CO2) can be absorbed int... Class II Abbott GmBH & Co. KG
Jul 20, 2017 Sekisui Diagnostics Sekure Chemistry Acetaminophen L3K , Ref. 506-30. The fi... Reagent carryover from Sekisui ACTH when utilized on the BEC AU 680 analyzer may lead to falsely ... Class II Beckman Coulter Inc.
Nov 29, 2016 Sekisui Diagnostics Ammonia L3K¿ Assay; Catalog Number: 293-80-91 and 293-10 ... Certain lots are showing an atypical decrease in optical density (OD) over time, which may result... Class II Sekisui Diagnostics P.E.I. Inc.
Jan 22, 2016 Sekure Chemistry Sekisui Diagnostics Acetaminophen L3K Assay, In-vitro Diagn... Crystal formation in the Color Reagent (R2) when left on board automated analyzers causing sample... Class II Sekisui Diagnostics P.E.I. 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.