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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
Jan 11, 2019 Ethyl Alcohol Enzymatic Assay, (a) REF 0220 (small test kit), (b) REF 0221 (l... Shelf life of the product may be reduced due to degradation of the assay. Class III Lin-Zhi International Inc
Feb 18, 2014 Single Analyte DAU Calibrator (5 mL) Norbuprenorphine: Cutoff Calibrator; I... Customer reported that the Synchron NBUP cutoff calibrator (10 ng/mL) could not be qualified thro... Class III Lin-Zhi International Inc
Feb 6, 2014 Cannabinoids DAU Calibrator Control Level 1 (37.5 ng/mL) This solution is ... Product catalog #s 0007c Cannabinoid 37.5 ng/mL Control Level 1 and 0008c Cannabinoid 62.5 Contr... Class II Lin-Zhi International Inc
Feb 6, 2014 Cannabinoids DAU Calibrator Control Level 1 (62.5 ng/mL) This solution is ... Product catalog #s 0007c Cannabinoid 37.5 ng/mL Control Level 1 and 0008c Cannabinoid 62.5 Cont... Class II Lin-Zhi International Inc
Oct 3, 2013 Single Analyte Urine DAU Control (5 m L Norbuprenorphine, Level II control ... Product catalog # A68825 Norbuprenorphine 13 ng/mL Level 2 Controls gives a decreased concentrati... Class III Lin-Zhi International 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.