Recall Z-1004-2026 · HQB Photocoagulator And Accessories

Vortex Surgical Inc.

Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe, Catalog Number VS0135.25;

Date	Dec 30, 2025 (initiated Nov 19, 2025)
Status	Open, Classified
Reason	Reason for the voluntary recall is some products in this lot are not passing through a 25ga cannula smoothly.
Root cause	Component design/selection
Action	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.
Quantity	221 units
Distribution	US and Japan
FDA record	Open on fda.gov

510(k) clearances named in this recall

K220263

Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgica
Vortex Surgical, Inc., Nov 3, 2022