Browse Device Recalls
726 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 726 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 726 FDA device recalls in NC.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 2, 2012 | Vacuette Quickshield Complete Plus, 21G x 1 (0.8 x 25 mm), Greiner bio-one. ... | : The Quickshield Complete Plus may have a defect (split at the base), which can cause the green ... | Class II | Greiner Bio-One North America, Inc. |
| Mar 22, 2012 | Manual Method 1: 480 Test Kit (PreCoat), Catalog/Model # 490529 | The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due ... | Class III | Tripath Imaging, Inc. |
| Mar 22, 2012 | PrepStain Installation Kit (PreCoat), Catalog/Model # 490528 | The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due ... | Class III | Tripath Imaging, Inc. |
| Mar 22, 2012 | PrepStain GN 480 Disposable Kit Catalog/Model 490542 This is a complete kit,... | The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due ... | Class III | Tripath Imaging, Inc. |
| Mar 22, 2012 | PrepStain Syringing Pipettes 240 (Catalog #490517) | The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due ... | Class III | Tripath Imaging, Inc. |
| Mar 22, 2012 | PrepStain GYN 480 Disposable Test Kit with PreCoat Slides (Catalog #490523 | The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due ... | Class III | Tripath Imaging, Inc. |
| Dec 8, 2011 | PrepStain PM Kit, T-AG (Catalog 490588); PrepStain PM Kit Europe (Catalog 490... | Some Prep Stain Kit, 1.2 DiTi Cones have been found to be leaking and the PrepStain Preparation k... | Class II | Tripath Imaging, Inc. |
| Dec 8, 2011 | PrepStain Upgrade Kit: 1.3.0.3/1.2 DiTi Cone. The PrepStain System is a li... | Some Prep Stain Kit, 1.2 DiTi Cones have been found to be leaking and the PrepStain Preparation k... | Class II | Tripath Imaging, Inc. |
| Dec 8, 2011 | PrepStain Kit: 1.2 DiTi Cone. The PrepStain System is a liquid-based thin ... | Some Prep Stain Kit, 1.2 DiTi Cones have been found to be leaking and the PrepStain Preparation k... | Class II | Tripath Imaging, Inc. |
| Dec 8, 2011 | PrepStain Slide Processor. The PrepStain System is a liquid-based thin lay... | Some Prep Stain Kit, 1.2 DiTi Cones have been found to be leaking and the PrepStain Preparation k... | Class II | Tripath Imaging, 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.