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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
Jan 5, 2018 Diamedix Is-EBV-EA-D IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic ... Contains a gel-like contaminant that may affect product performance. Class III Diamedix Corporation
Jan 5, 2018 Diamedix Is-Mumps IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use... Contains a gel-like contaminant that may affect product performance. Class III Diamedix Corporation
Mar 26, 2015 Diamedix Is-CMV IgG Test Kit Product contained an incorrect substrate. Class II Diamedix Corporation
Oct 20, 2014 Diamedix Is-Mumps IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an EIA p... A gel-like substance was found in kit component, sample diluent , that could potentially compromi... Class II Diamedix Corporation
Oct 20, 2014 Diamedix Is-EBV-EA-D IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an EI... A gel-like substance was found in kit component, sample diluent , that could potentially compromi... Class II Diamedix Corporation
Oct 20, 2014 Diamedix Is-EBV-VCA IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an EIA... A gel-like substance was found in kit component, sample diluent , that could potentially compromi... Class II Diamedix Corporation
Aug 6, 2012 The Is-anti-Sm test kits****Catalog No: 720-240*** Product Usage: The Diame... Diamedix Corporation recalled their Is-anti-Sm Test Kit due to the Positive Control recovering hi... Class II Diamedix 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.