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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
Sep 5, 2024 NxTAG Respiratory Pathogen Panel, REF: I051C0447 Respiratory pathogen panel may report an elevated rate (7.6% predicted probability of occurrence... Class II Luminex Molecular Diagnostics Inc
Sep 5, 2024 NxTAG Respiratory Pathogen Panel +SARS-CoV-2, REF: I056C0468 Respiratory pathogen panel may report an elevated rate (7.6% predicted probability of occurrence... Class II Luminex Molecular Diagnostics Inc
Jul 16, 2019 xTAG Respiratory Viral Panel (RVP): Box Label: xTAG RVP (Respiratory Viral ... The Assay may give a false negative result when detecting and subtyping Influenza A (H3) and dete... Class II Luminex Molecular Diagnostics
Feb 22, 2019 xTAG Gastrointestinal Pathogen Panel intended for the simultaneous qualitativ... Reports have been received of lower MS2 MFI values when using the panel. Class II Luminex Molecular Diagnostics

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.