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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
Jun 4, 2025 Brand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog Numbe... An incoming complaint reported that the expiration date on the kit box label and Certificate of A... Class III DRG International, Inc.
Oct 7, 2024 DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361 The user of the assay may either face a failure message during re-calibration of the Hybrid.XL in... Class II DRG International, Inc.
Sep 13, 2024 17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitat... The High and Low Control acceptance ranges in the Certificate of Analysis (CofA) did not match th... Class III DRG International, Inc.
Jul 5, 2024 Product Name: Salivary Testosterone ELISA Model/Catalog Number: SLV-3013 Pr... Invalid Controls. The Low Control is out of range; too high which causes invalid runs that would... Class III DRG International, Inc.
Dec 21, 2021 C-Peptide ELISA : IVD measurement of C-Peptide in serum, plasma (EDTA-, hepar... ODs of the standards too low(< 0.6 ODmax) may cause invalid runs, delayed patient results are pos... Class II DRG International, Inc.
Oct 18, 2021 Total Thyroxine (T4) ELISA; REF EIA-1781 Firm has identified two lots of product that do not meet product shelf life, resulting in failed ... Class II DRG International, 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.