← FDA ENFORCEMENT
Z-1004-2026Class II

Vortex Surgical Inc.

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Vortex Surgical Inc.
Product type
Device
Status
Ongoing
Report date
2026-01-07
Distribution
US and Japan
Firm state
MO
Product quantity
221 units
Initiated by
Voluntary: Firm initiated
Reason for recall

Reason for the voluntary recall is some products in this lot are not passing through a 25ga cannula smoothly.

Product description

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

Code / lot info

UDI: Box (01)00810123483617(17)281001(10)2509040, Pouch (01)00810123483549(17)281001(10)2509040. Lot Number 2509040

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →