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Browse Device Recalls

11 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 11 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 11 FDA device recalls.

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DateProductReasonClassFirm
Dec 15, 2025 TS-10/TS-10H Tube Sorter, automatic sorting system for sorting barcoded sampl... Under specific conditions, the lift's electromagnetic holding force may disengage unexpectedly, a... Class II Sysmex America, Inc.
Jan 6, 2025 Sysmex PS-10 Sample Preparation System with software version 1.5 and 1.6., Ca... Sysmex was made aware of a report of false results due to carry-over caused by the sporadic omiss... Class II Sysmex America, Inc.
Jul 6, 2020 Sysmex PS-10 Sample Preparation System Catalog number:BQ716341 - Product Usa... Insufficient amount of antibody without an error message or alarm Class II Sysmex America, Inc.
Mar 9, 2020 The CF-70 instrument (product code: LXG; Regulation Number: 862.2050) receive... Software mismatch-When the software versions between the SP-50 and CF-70 are not matched, and an ... Class II Sysmex America, Inc.
Jan 21, 2020 Sysmex CV-11 Sample Unit, an integrated modular sampler that conveys specimen... When excessive amounts of urine spills on the rack transport track and reaches the electrical co... Class II Sysmex America, Inc.
Jul 27, 2018 Sysmex XN-Series Fluorocell PLT, Catalog #CD994563. Distributed in the U.S.... The fluorescent platelet counts (PLT-F) and immature platelet fraction (IPF) values can be falsel... Class II Sysmex America, Inc.
Sep 8, 2017 Sysmex Fluorocell(R) PLT Fluorocell PLT is used to stain platelets in a dil... There is potential that fluorescent platelet (PLT-F) and immature platelet fraction (IPF%, #) res... Class II Sysmex America, Inc.
Mar 31, 2013 The UF-1000i is a fully automated urine particle analyzer intended for vitro ... The current Century Break patch did not contain the same setting for the Century Break year for b... Class II Sysmex America, Inc.
Jun 1, 2012 Sysmex XE-2100 Automated Hematology System; an automated differential cell co... There is a variation of reticulocyte counts between XE Series (XE-2100, XE-5000) and XT-Series (X... Class II Sysmex America, Inc.
Jun 1, 2012 Sysmex XE-5000 Automated Hematology System; an automated differential cell co... There is a variation of reticulocyte counts between XE Series (XE-2100, XE-5000) and XT-Series (X... Class II Sysmex America, Inc.
Jun 1, 2012 Sysmex XE-2100C Automated Hematology System; an automated differential cell c... There is a variation of reticulocyte counts between XE Series (XE-2100, XE-5000) and XT-Series (X... Class II Sysmex America, 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.