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Browse Device Recalls

8 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 8 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 8 FDA device recalls.

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DateProductReasonClassFirm
Dec 3, 2024 The FastPack IP Sex Hormone Binding Globulin Immunoassay, Part #25000081, is ... Three lots of the FastPacks kitted into the FastPack SHBG Complete Kits were labeled with the inc... Class III Qualigen Inc
Aug 26, 2024 FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the F... Thyroid Stimulating Hormone (TSH) calibrator card has an incorrect barcode linked to incorrect in... Class II Qualigen Inc
Nov 6, 2019 The FastPack System Comlete Immunoassay Kit Immunoassay for the Quantitati... The chemiluminescent immunoassay has been noted to have higher than expected results which may re... Class II Qualigen Inc
Jul 7, 2017 Qualigen(R) The FastPack(R) IP Vitamin D Complete Immunoassay Kit, catalog nu... Specific lots have been reported to produce falsely lower than expected results for Vitamin D Class II Qualigen Inc
Nov 8, 2013 FastPack Free T4 Immunoassay Chemilunescence assay for the determination of... Qualigen initiated this recall because the FastPack kit may cause lower than expected results due... Class II Qualigen Inc
Nov 8, 2013 FastPack Total PSA Immunoassay Chemilunescence assay for the determination ... Qualigen initiated this recall because the FastPack kit may cause lower than expected results due... Class II Qualigen Inc
Nov 8, 2013 FastPack Testosterone Immunoassay Chemilunescence assay for the determinati... Qualigen initiated this recall because the FastPack kit may cause lower than expected results due... Class II Qualigen Inc
Nov 8, 2013 FastPack Free T4 Immunoassay FastPack Vitamin D Immunoassay Chemilunescen... Qualigen initiated this recall because the FastPack kit may cause lower than expected results due... Class II Qualigen 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.