Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe, Catalog Number VS0135.25;
This recall is currently active, issued December 30, 2025. It was issued by Vortex Surgical Inc..
- Company
- Vortex Surgical Inc.
- Recall Initiated
- November 19, 2025
- Posted
- December 30, 2025
- Recall Number
- Z-1004-2026
- Quantity
- 221 units
- Firm Location
- Saint Charles, MO
- Official Source
- View on FDA website ↗
Reason for Recall
Reason for the voluntary recall is some products in this lot are not passing through a 25ga cannula smoothly.
Distribution
US and Japan
Lot / Code Info
UDI: Box (01)00810123483617(17)281001(10)2509040, Pouch (01)00810123483549(17)281001(10)2509040. Lot Number 2509040
Root Cause
Component design/selection
Action Taken
Vortex Surgical Inc. issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 11/19/2025 via email. The notice explained the issue, risk to health, and requested the use of the product be discontinued. The firm requested the response to be emailed to: ARitts@VortexSurgical.com for replacement or refund. Customer Service will provide a return label for any unused products.