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Browse Device Recalls

6 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 6 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 6 FDA device recalls.

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DateProductReasonClassFirm
May 24, 2023 NeuMoDx Cartridge-used for extraction, purification, amplification and detect... Top label on some of the NeuMoDx cartridges within these lots may have been incorrectly applied d... Class II NeuMoDx Molecular Inc
May 15, 2023 NeuMoDx SARS-CoV-2 Assay -IVD intended for the qualitative detection of SARS... Potential for lot number discrepancies between the test strip packaging and the barcode label app... Class III NeuMoDx Molecular Inc
May 13, 2022 NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Model No. 300900 There is a potential for reduced analytical sensitivity for samples in the 1x - 3x LOD range for ... Class II NeuMoDx Molecular Inc
Feb 18, 2022 NeuMoDx Cartridge-For in vitro diagnostic use with NeuMoOx Molecular Systems ... Potential for false positive results for SARS-CoV-2 in identified lots of cartridges, when used i... Class II NeuMoDx Molecular Inc
Jan 21, 2022 NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Ref # 300900 (marketed und... A risk for product contamination was identified for the affected product lot. If used, there is a... Class II NeuMoDx Molecular Inc
May 4, 2021 NeuMoDx Cartridge, For In Vitro Diagnostic Use on the NeuMoDx 288 and NeuMoDx... There is a potential for false positive results when certain lots of cartridges are used in conju... Class II NeuMoDx Molecular 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.