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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
May 13, 2024 Sight OLO CBC Test Kit, Model/Catalog Number: TK1. A disposable cartridge and... One Test Kit lot (TK1-10114) shows a positive bias in the platelet count due to bacterial contami... Class II SIGHT DIAGNOSTICS LTD
Jun 14, 2022 Sight OLO, Automated Hematology Analyzer, Catalog No. OLO-U1 The default reference ranges for MCH, MCHC, and RDW for age group "Child 2-11y" are mixed up and ... Class II SIGHT DIAGNOSTICS LTD
Jan 20, 2022 The Sight OLO device is a computer vision based platform for blood analysis. ... In instances where custom reference ranges were configured on the device post installation, a po... Class II SIGHT DIAGNOSTICS LTD
Mar 17, 2021 Sight OLO-E1/U1 Software and Operators Manual Software v2.56.1 Catalog #: 1... Discrepancy in labeling between the adult CBC reference ranges presented in the OLO Operator's Ma... Class II SIGHT DIAGNOSTICS LTD

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.