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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
Oct 31, 2023 ZEUS ELISA Parvovirus B19 IgG Test System, Product Number SM9Z7701M The organization completed a product improvement process to the conjugate found within the certai... Class II Zeus Scientific, Inc.
Oct 31, 2023 ZEUS ELISA Parvovirus B19 IgM Test System, Product Number SM9Z7701G The organization completed a product improvement process to the conjugate found within the certai... Class II Zeus Scientific, Inc.
Aug 12, 2019 ZEUS ELISA Parvovirus B19 IgM Test System, UDI 00845533001755 - Product Usage... FDA inspection identified that due to increased positivity (false positives) on the Parvovirus B1... Class II Zeus Scientific, Inc.
Jul 22, 2019 Dynex DSX Software-IVD ELISA Assays effected as follows: DSX Assay File Sof... Assay files used on the open Dynex DSX Instrument to process IVD ELISA samples-programming error ... Class II Zeus Scientific, 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.