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Browse Device Recalls

712 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 712 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 712 FDA device recalls in NC.

Clear
DateProductReasonClassFirm
Sep 30, 2011 CMS-8162-R1 Fox Chase Specials Pack containing 2 oz. bottle PVP Prep Solution... The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solutio... Class I Custom Medical Specialties, Inc.
Sep 30, 2011 CMS-4501-R1 Custom HSG Tray containing 2 oz. PVP Prep Bottle Product Usag... The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solutio... Class I Custom Medical Specialties, Inc.
Sep 30, 2011 BR980-9600 Hysteroscopy Sterile Procedure Kit containing 2 oz. bottle PVP Pre... The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solutio... Class I Custom Medical Specialties, Inc.
Sep 30, 2011 CMS-2981-R3 Arthrogram Tray containing 2 oz. bottle PVP Prep Solution CMS-... The firm saw on the FDA web site a recall by the manufacturer due to no microbial testing in plac... Class II Custom Medical Specialties, Inc.
Sep 30, 2011 CMS-8412-R2 Custom Cysto Pack containing 2 oz. bottle of PVP Prep Solution ... The firm saw on the FDA web site a recall by the manufacturer due to no microbial testing in plac... Class II Custom Medical Specialties, Inc.
Sep 30, 2011 CMS-8457 Hysteroscopic Sterilization Pack containing 4 oz. bottle PVP Prep ... The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solutio... Class I Custom Medical Specialties, Inc.
Sep 30, 2011 CMS-4219-R2 Custom Laser Pack containing 2 oz bottles PVP Prep Solution Th... The firm saw on the FDA web site a recall by the manufacturer due to no microbial testing in plac... Class II Custom Medical Specialties, Inc.
Sep 30, 2011 CMS-2586 Custom Amnio Tray containing 2 oz. bottle PVP Prep Solution Produ... The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solutio... Class I Custom Medical Specialties, Inc.
Sep 30, 2011 CMS-4316 Custom Vein Tray containing 4 oz. bottle PVP Prep Solution Produc... The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solutio... Class I Custom Medical Specialties, Inc.
Sep 30, 2011 CMS-2890 Custom Needle Local Tray containing PVP Prep Pad The PV contained... The firm saw on the FDA web site a recall by the manufacturer due to no microbial testing in plac... Class II Custom Medical Specialties, Inc.
Sep 30, 2011 CMS-4873 Custom CT Biopsy Tray, CMS-4873-R1 Custom CT Biopsy Tray containing ... The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solutio... Class I Custom Medical Specialties, Inc.
Sep 30, 2011 CMS-8450-R1 Custom Vein Tray containing 4 oz. bottle PVP Prep Solution Pro... The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solutio... Class I Custom Medical Specialties, 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.