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Browse Device Recalls

8 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 8 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 8 FDA device recalls.

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DateProductReasonClassFirm
Sep 29, 2023 Alinity c Iron Reagent, Reference Number 08P3920 A high recovery of Iron assay has been observed at some customer sites. Internal studies confirm... Class II Sentinel CH SpA
Sep 29, 2023 IRON assay, Reference Numbers 6K95-41 and 6K95-30 A high recovery of Iron assay has been observed at some customer sites. Internal studies confirm... Class II Sentinel CH SpA
Jul 29, 2021 Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (ref 07P5605) - P... Calibrator vials were incorrectly labeled. Use of incorrectly labeled vials will cause the instru... Class III Sentinel CH SpA
Apr 30, 2021 ACE Control Set - IVD Control set for the quantitative determination of Angio... Claim for stability after reconstitution from lyophilized to liquid form does not meet the requir... Class III Sentinel CH SpA
Jun 28, 2019 Alinity c Lithium Reagent Kit- intended for the quantitation of lithium in se... Added an additional SmartWash parameter for the Lithium and Alinity c Lithium Reagent Kit, cata... Class II Sentinel CH SpA
Jun 28, 2019 MULTIGENT Lithium-intended for the quantitation of lithium in serum or plasm... Added an additional SmartWash parameter for the Lithium and Alinity c Lithium Reagent Kit, cata... Class II Sentinel CH SpA
May 22, 2017 MULTIGENT Creatinine (Enzymatic), Catalog Numbers 8L24-31 and 8L24-41; IVD. ... Reagent 1 component may result in Quality Control values shifting out of acceptable range, which ... Class II Sentinel CH SPA
Sep 22, 2015 Sentinel MULTIGENT Ammonia Ultra Reagent, In-Vitro Diagnostic for ammonia mea... Results for ammonia are below the linear range of the assay for samples that have been collected ... Class II Sentinel CH SpA

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.