Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe, Catalog Number VS0135.25;
FDA Recall #Z-1004-2026 — Class II — November 19, 2025
Product Description
Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe, Catalog Number VS0135.25;
Reason for Recall
Reason for the voluntary recall is some products in this lot are not passing through a 25ga cannula smoothly.
Recalling Firm
Vortex Surgical Inc. — Saint Charles, MO
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
221 units
Distribution
US and Japan
Code Information
UDI: Box (01)00810123483617(17)281001(10)2509040, Pouch (01)00810123483549(17)281001(10)2509040. Lot Number 2509040
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated