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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
Nov 7, 2024 DiaSorin LIAISON Q.S.E.T. Device Plus, REF 319060; intended for use in the pr... Customer complaints were received alleging leaking devices and insufficient buffer volume. Diasor... Class II Diasorin Inc.
Dec 13, 2023 DiaSorin LIAISON HSV-2 Type Specific IgG, REF 310620 DiaSorin has identified that lots 136344, 136344A, 136344B, 136344C, 136520, 136520A, 136520B, 13... Class II Diasorin Inc.
Nov 23, 2020 LIAISON 1-84 PTH Assay - Product Usage: is an in vitro chemiluminescent immun... Potential for system to produce falsely elevated parathyroid hormone (PTH) results from patient s... Class II Diasorin Inc.
Jul 17, 2020 Parvovirus B19 IgG EIA kit Part No. V519IGUS Printed label inside the box lid of the Parvovirus has the incorrect Lot Specific Constant value Class II Diasorin Inc.
Jul 13, 2016 LIAISON Estradiol II Gen, 310680, 310680-CN The DiaSorin LIAISON Estradiol... DiaSorin is issuing an urgent medical device correction for the LIAISON¿ Estradiol II Gen assay. ... Class II Diasorin Inc.
Mar 16, 2015 DiaSorin, PRO-Trac II Tacrolimus ELISA kit, REF 32400 and 32400-CN. Product ... Instability in the PRO-Trac II Tacrolimus ELISA kit which may cause falsely elevated patient resu... Class II Diasorin 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.