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Browse Device Recalls

9 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 9 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 9 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...

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.