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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
Aug 29, 2018 IM Abbott Alinity ci-series (abdicqii) accessory driver v8.00.0001 software p... Quality control results are not processed for Abbott Diagnostics Alinity ci series (abdicqii) ins... Class II Data Innovations, LLC
Oct 23, 2014 JResultNet drivers using ASTM coding language. Calculator/data processing mo... Software issue resulting in the results of one patient potentially being associated with another. Class II Data Innovations, LLC
Aug 15, 2014 ProVue Instrument Driver for JResultNet (ProVue.jrm) v. 1.5.3 and below JR... Potential issues with the ProVue driver have been identified which may cause data to be misassoci... Class II Data Innovations, LLC
Mar 20, 2014 enGen (TM) Laboratory Automation System configured with Data Innovations, LLC... Software Anomaly: Ortho Clinical Diagnostics (OCD) has become aware that if a sample requires fol... Class II Ortho-Clinical Diagnostics

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.