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Browse Device Recalls

11 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 11 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 11 FDA device recalls.

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DateProductReasonClassFirm
Feb 15, 2017 Legionella IFA (IF0950) intended for qualitatively detecting and semi-quantit... After a submission for CLIA database update from Focus Diagnostics to DiaSorin Molecular,the comp... Class II Focus Diagnostics Inc
Feb 15, 2017 Legionella IFA Substrate Slide (IF0951) intended for qualitatively detecting ... After a submission for CLIA database update from Focus Diagnostics to DiaSorin Molecular,the comp... Class II Focus Diagnostics Inc
Feb 10, 2016 Simplexa Flu A/B & RSV Direct (MOL2650) with Direct Amplification Disc (MOL14... Focus Diagnostics is recalling the Direct Amplification Discs (DAD) supplied with the Simplexa HS... Class II Focus Diagnostics Inc
Feb 10, 2016 Simplexa HSV 1&2 Direct (MOL2150) with Direct Amplification Disc (MOL1451, MO... Focus Diagnostics is recalling the Direct Amplification Discs (DAD) supplied with the Simplexa HS... Class I Focus Diagnostics Inc
Feb 10, 2016 Simplexa Group A Strep Direct (MOL2850) with Direct Amplification Disc (MOL14... Focus Diagnostics is recalling the Direct Amplification Discs (DAD) supplied with the Simplexa HS... Class I Focus Diagnostics Inc
Oct 2, 2015 Focus Diagnostics Anaplasma Phagocytophilum IFA IgM Test Kit, Model No. IF145... Focus Diagnostics is recalling the Anaplasma phagocytophilum IFA IgM kit because of the potential... Class II Focus Diagnostics Inc
Mar 15, 2015 STRATIFY JCV DxSelect, Model No. EL1950. Assay for detection of antibodies t... Focus Diagnostics is recalling the Stratify JCV Dx Select due to the use of a non-conforming batc... Class II Focus Diagnostics Inc
May 15, 2014 Simplexa" Flu A/B & RSV Direct, Model Number: MOL2650. 510(k) K120413 ... Focus Diagnostics is providing an urgent safety notice for a correction to the labeling for Simpl... Class II Focus Diagnostics Inc
Feb 4, 2014 Simplexa Flu AlB & RSV Direct Assay Kits, intended for use as an aid in the d... Focus Diagnostics initiated the recall of the certain Simplexa Flu AlB & RSV Direct assay kits d... Class II Focus Diagnostics Inc
Jan 10, 2014 Simplexa Flu A/B & RSV Direct assay, Model MOL2650. The Focus Diagnostics ... Focus Diagnostics is initiating an urgent safety notice correction for Simplexa Flu A/B & RSV Dir... Class II Focus Diagnostics Inc
Oct 3, 2012 West Nile Virus IgG DxSelect" kit Catalog No. EL0300G Kit Lots 122150, 12215... The firm recalled due to higher reactivity with some samples in the effected lots, which may refl... Class III Focus Diagnostics 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.