Browse Device Recalls
14 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 14 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 14 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 28, 2014 | Bionector Needleless connector. Bionector is a multi-purpose catheter accesso... | Vygon has uncovered potential problems with membrane elasticity in the 896.038, Bionector Needlel... | Class II | Vygon Corporation |
| Dec 17, 2012 | Churchill Medical Systems, Inc. A Vygon Company - All sizes of CMS-CT6T225 6F... | Product was packaged with the incorrect introducer needle. The kit label indicates a "safety" ne... | Class II | Vygon Corporation |
| May 11, 2012 | Vygon VY(TM)Flush Heparin Lock Flush Syringes, 10 Units per mL, 5mL in a 10mL... | Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringe... | Class II | Vygon Corporation |
| May 11, 2012 | Churchill Medical Systems, Inc. VAD ACCESS TRAY Kit Prefilled syringes inc... | Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringe... | Class II | Vygon Corporation |
| May 11, 2012 | Vygon VY(TM)Flush Heparin Lock Flush Syringes, 1 Unit per mL, 3mL in a 10mL F... | Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringe... | Class II | Vygon Corporation |
| May 11, 2012 | Churchill Medical Systems, Inc. DRESSING CHANGE KIT Prefilled syringes inc... | Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringe... | Class II | Vygon Corporation |
| May 11, 2012 | Churchill Medical Systems, Inc. A VYGON COMPANY PICC INSERTION TRAY Prefil... | Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringe... | Class II | Vygon Corporation |
| May 11, 2012 | Vygon VY(TM)Flush Heparin Lock Flush Syringes, 100 Units per mL, 3mL in a 10m... | Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringe... | Class II | Vygon Corporation |
| May 11, 2012 | Churchill Medical Systems, Inc. A VYGON Company PICC LINE TRAY Kit Prefill... | Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringe... | Class II | Vygon Corporation |
| May 11, 2012 | Vygon VY(TM)Flush Heparin Lock Flush Syringes, 10 Units per mL, 3mL in a 10mL... | Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringe... | Class II | Vygon Corporation |
| May 11, 2012 | Churchill Medical Systems, Inc. A VYGON Company PICC INSERTION TRAY Kit Pr... | Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringe... | Class II | Vygon Corporation |
| May 11, 2012 | Churchill Medical Systems, Inc. VAD ACCESS TRAY Kit Prefilled syringes inc... | Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringe... | Class II | Vygon Corporation |
| May 11, 2012 | Vygon VY(TM)Flush Heparin Lock Flush Syringes, 100 Units per mL, 5mL in a 10m... | Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringe... | Class II | Vygon Corporation |
| May 11, 2012 | Churchill Medical Systems, Inc. PORT-A-CATH Tray Kit Prefilled syringes in... | Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringe... | Class II | Vygon Corporation |
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.