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Browse Device Recalls

19 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 19 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 19 FDA device recalls.

Clear
DateProductReasonClassFirm
Jun 15, 2017 Various custom surgical kits manufactured for CMS, CUSTOM MEDICAL SPECIALTIES... The firm manufactured and distributed custom surgical kits which contained BD SafetyGlide" 22GA 1... Class II Custom Assemblies Inc
Sep 20, 2016 CMS-2193-R7 and CMS-1911-R3 Custom Biopsy Tray containing a BD 10cc LL Syring... Sterility of syringe product could not be assured. Class II Custom Medical Specialties, Inc.
Jul 12, 2013 5 x 93 US Probe Cover CMS-6049, Sterile, Single Patient Use. Custom Medical S... No endotoxin (LAL) testing to proper level. Class II Custom Medical Specialties, Inc.
Sep 30, 2011 CMS-5284 Custom Myelogram Tray containing 2 oz. bottle PVP Prep Solution P... 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-8495-R5 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.
Sep 30, 2011 CMS-8325-R2 Abington Radiology Drainage Pack and CMS-8325-R3 Abington Radiolo... 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-4975 HSG Tray containing 4 oz. bottle PVP Prep Solution Product Usage:... 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-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.