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Browse Device Recalls

5 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5 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 5 FDA device recalls.

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DateProductReasonClassFirm
May 24, 2023 EliA GBM Wells, Material Number 14551401, for Phadia 250, 2500, and 5000. In ... Complaints that specific samples produced false positive EliA GBM results. A positive signal was ... Class II Phadia Ab
Jul 9, 2019 Phadia" 1000 Model # 12-3800-01 Product Usage: The instrument is fully i... code 7-102 Liquid Sensor Error Class II Phadia Ab
May 10, 2019 EliA RF IgM Well, REF 14-5600-01 Product Usage: Usage: EliA RF IgM is in... Potential for reporting low assay results Class II Phadia Ab
Nov 20, 2017 Phadia Prime software, article number 12-4101-00, as used in combination with... We want to inform all Phadia 250 system operators performing EliA Assays not to use the function ... Class II Phadia Ab
Dec 28, 2015 EliA SmDP Well, Article Number 14-5624-01 Product Usage: EliA SmDP is int... All equivocal and positive results (greater or equal 7 EliA U/ml) on EliA SmDP well lot 0018 may ... Class II Phadia Ab

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.