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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
Feb 10, 2020 SPICE (JWH-018) CC443 Corrections are being made to the device labeling regarding its intended use, to include a statem... Class II Carolina Liquid Chemistries Corp
Jan 20, 2020 Fentanyl Reagent Kit, Product N. CC444, Contains: FENT R1 Reagent and FENT R2... Labeled for diagnostic use and sold to clinical labs without a 510(k). Firm corrected labeling t... Class II Carolina Liquid Chemistries Corp
Jan 16, 2019 CAROLINA(R) LIQUID CHEMISTRIES CORP. ETHA RGT. KIT, IVD, REF ST321 Supplier testing showed that the absorbance rate of the Ethyl Alcohol Assay did not meet internal... Class III Carolina Liquid Chemistries
Jan 16, 2019 CAROLINA(R) LIQUID CHEMISTRIES CORP. ETHA RGT. KIT, IVD, REF ST321 Class III Carolina Liquid Chemistries

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.