FDA recall Z-1004-2026

Vortex Surgical Inc. · Class II · device

Product

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.

Distribution

US and Japan

Key facts

Status
Ongoing
Initiation date
2025-11-19
Report date
2026-01-07
Voluntary/Mandated
Voluntary: Firm initiated
Location
Saint Charles, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1004-2026