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Browse Device Recalls

33 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 33 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 33 FDA device recalls.

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DateProductReasonClassFirm
Sep 24, 2019 4Fr x 20cm Single Lumen CT Midline Basic Tray, Product Code: VYML4S1001 Potential that 3Fr size catheter placed in the catheter tray instead of 4Fr for the 4Fr x 20cm Si... Class II Vygon MFG, Inc., dba/ Churchill Medical Systems...
Oct 3, 2017 Vygon IV Start Convenience Kits; Product Codes AMS-623T and AMS-626TGSLF. ... The Iodine Prep Pads within the Vygon IV Start Convenience Kits, had stability samples that were ... Class II Vygon MFG, Inc., dba/ Churchill Medical Systems...
Jul 24, 2017 20Ga x .75 LifeGuard Huber Needle with Y-site. Product Code: CLGY-2034. Vygon is conducting a voluntary recall of the products and lots listed in this recall, being ini... Class II Vygon MFG, Inc., dba/ Churchill Medical Systems...
Jul 24, 2017 Nutrisafe 2 35 mL Syringe for Safety Connection. Product Code: 1015.352M Vygon is conducting a voluntary recall of the products and lots listed in this recall, being ini... Class II Vygon MFG, Inc., dba/ Churchill Medical Systems...
Jul 24, 2017 CVC Tray Pediatrics. Product Code: AMS-9335CP-2. Vygon is conducting a voluntary recall of the products and lots listed in this recall, being ini... Class II Vygon MFG, Inc., dba/ Churchill Medical Systems...
Jul 24, 2017 19Ga x 1 Huber Needle Set. Product Code: MBS-1910. Vygon is conducting a voluntary recall of the products and lots listed in this recall, being ini... Class II Vygon MFG, Inc., dba/ Churchill Medical Systems...
Jul 24, 2017 3-Way Standardbore Stopcock. Product Code: AMS-100. Vygon is conducting a voluntary recall of the products and lots listed in this recall, being ini... Class II Vygon MFG, Inc., dba/ Churchill Medical Systems...
Feb 20, 2017 AMS-636, 60" Microbore extension set. Product Usage: Accessory devices us... Incorrect priming volume printed on the device package. Class II Vygon MFG, Inc., dba/ Churchill Medical Systems...
Nov 18, 2016 AMS-651, 120" Microbore extension set with slide clamp; Product Code: AMS-651... Incorrect priming volume is printed on the device package. Class II Vygon MFG, Inc., dba/ Churchill Medical Systems...
Jan 15, 2015 Bifircated Extension Set, Product Code: BN-828 Accessory device used to admi... Potential for leaking caused by insufficient bond between needleless device and female luer. Class II Churchill Medical Systems, Inc.
Jan 15, 2015 7" Standard Bore High Pressure Ext Set, Product Code: CMS-809 Accessory devi... Potential for leaking caused by insufficient bond between needleless device and female luer. Class II Churchill Medical Systems, Inc.
Jan 15, 2015 Bifurcated set with check vales and Bionectors, Product Code: BN-2082CV Acce... Potential for leaking caused by insufficient bond between needleless device and female luer. Class II Churchill Medical Systems, Inc.
Jan 15, 2015 8" Standard Bore Ext Set, Product Code: BN-481 Accessory device used to admi... Potential for leaking caused by insufficient bond between needleless device and female luer. Class II Churchill Medical Systems, Inc.
Jan 15, 2015 7" High Pressure Set with Bionector, Product Code: CMS-808 and CMS-808-1 Acc... Potential for leaking caused by insufficient bond between needleless device and female luer. Class II Churchill Medical Systems, Inc.
Jan 15, 2015 6" Trifurcated Extension Set, Product Code: AMS-375-1 Accessory device used ... Potential for leaking caused by insufficient bond between needleless device and female luer. Class II Churchill Medical Systems, Inc.
Jan 15, 2015 4" Microbore Double Lumen Set with Bionector, Product Code: BN-208 Accessory... Potential for leaking caused by insufficient bond between needleless device and female luer. Class II Churchill Medical Systems, Inc.
Jan 15, 2015 7" Standard Bore High Pressure Ext Set, Product Code: CMS-809 Accessory devi... Potential for leaking caused by insufficient bond between needleless device and female luer. Class II Churchill Medical Systems, Inc.
Jan 15, 2015 6" Trifurcated set with Bionectors, Product Code: BN-944 Accessory device us... Potential for leaking caused by insufficient bond between needleless device and female luer. Class II Churchill Medical Systems, Inc.
Jan 15, 2015 4" Microbore Trifurcated Ext set, Product Code: BN-308 Accessory device used... Potential for leaking caused by insufficient bond between needleless device and female luer. Class II Churchill Medical Systems, Inc.
Jan 15, 2015 4" Microbore T-Port Set, Product Code: BN-448 Accessory device used to admin... Potential for leaking caused by insufficient bond between needleless device and female luer. Class II Churchill Medical Systems, Inc.
Jan 15, 2015 4" Trifurcated set with Bionectors and check valves, Product Code: BN-3082CV ... Potential for leaking caused by insufficient bond between needleless device and female luer. Class II Churchill Medical Systems, Inc.
Jan 7, 2014 AMS-530 7 Microbore Trifurcated Extension sets Product Usage: Intravas... Defective component may cause extension sets to leak. Class II Churchill Medical Systems, Inc.
Aug 12, 2013 Central Dressing Change Kit; AMS-8464CP- 6. Vygon Central Dressing Change K... Microbore tubing disconnecting from male luers on the extension sets. Class II Churchill Medical Systems, Inc.
Aug 12, 2013 Vygon 14 Microbore Extension Set with Bionector, CMS-814-1. The CMS-814-1 is ... Microbore tubing disconnecting from male luers on the extension sets. Class II Churchill Medical Systems, Inc.
Jan 21, 2013 Lifeguard Infusion Set with Smartsite, 20Ga, 1, CLGY-2010 Huber type needl... The label on the device states that the item number is CLGY-2210 when the item number on the devi... Class II Churchill Medical Systems, Inc.
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 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 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 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 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 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.