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Browse Device Recalls

15 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 15 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 15 FDA device recalls.

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DateProductReasonClassFirm
Dec 5, 2025 Revogene C. difficile, in vitro diagnostic assay intended for use with the Re... The affected lots show a decline in performance over time, which may lead to false-negative results. Class II Meridian Bioscience Inc
Oct 7, 2025 Meridian Bioscience, Group B Streptococcus, Catalog Number 480050, Nucleic Ac... The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the poten... Class II Meridian Bioscience Inc
Oct 7, 2025 Meridian Bioscience, alethia c. Difficile, Catalog Number 480050, Nucleic Ac... The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the poten... Class II Meridian Bioscience Inc
Oct 19, 2023 Para-Pak Clean Vial-For the collection, transportation, preservation, and exa... Plastic vials contain a manufacturing defect may cause an increased risk of leakage and presents ... Class II Meridian Bioscience Inc
Oct 19, 2023 Para-Pak Zn-PVA/10% Formalin-for the routine collection, transportation, pres... Plastic vials contain a manufacturing defect may cause an increased risk of leakage and presents ... Class II Meridian Bioscience Inc
Oct 19, 2023 Cardinal Health Clean Stool Transportation System-For the collection, transpo... Due to a manufacturing defect, certain Para-Pak vials may be at risk for leakage. Class II Meridian Bioscience Inc
Dec 15, 2022 Revogene SARS-CoV-2_IVD real-time RT-PCR test intended for the qualitative d... Leakage of the original specimen from the plastic microfluidic cartridge (PIE), possibility that ... Class II Meridian Bioscience Inc
Jun 22, 2022 Revogene, Catalog no. 610210. IVD test instrument When a run is aborted, the cooling period protection does not occur and the user is able to open ... Class II Meridian Bioscience Inc
Feb 15, 2022 Revogene, For In Vitro Diagnostic use in performing nucleic acid testing in c... The photomultiplier tube, may have compromised functionality in some instruments. As a result, th... Class II Meridian Bioscience Inc
Apr 8, 2021 Revogene RNA Software Upgrade Kit Revogene RNA Software Upgrade USBs Catalo... Emergency Use Application (EUA) application withdrawn as false negative results reported Class II Meridian Bioscience Inc
Apr 8, 2021 Revogene SARS-CoV-2 Catalog Number: 410700 IVD for real-time Reverse Tra... Emergency Use Application (EUA) application withdrawn as false negative results reported Class II Meridian Bioscience Inc
Feb 8, 2021 The ImmunoCard Mycoplasma EIA detects the presence of IgM to M. pneumoniae in... Use of the kits after incorrect storage could lead to a potential false-negative or invalid resul... Class II Meridian Bioscience Inc
Dec 17, 2018 PREMIER Cryptococcal Antigen, Catalog Number 602096 Product Usage: The PR... An enzyme reagent included in the kit is not maintaining stability through claimed product expira... Class II Meridian Bioscience Inc
Nov 8, 2016 PREMIER EHEC and PREMIER EHEC Bulk. Internal testing has demonstrated that the indicated kit lots produce false positive results when... Class II Meridian Bioscience Inc
Apr 22, 2014 illumipro-10 Incubator/Reader, Meridian Bioscience, Inc. The illumipro-10 ... Illumipro-10 instruments may have Block B chambers operating at an incorrect temperature as a res... Class II Meridian Bioscience 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.