Recall Z-1004-2026— Vortex Surgical Inc.

Name: FDA recall Z-1004-2026
Creator: U.S. Food and Drug Administration
Published: 2025-11-19

Class II · Ongoing

Class II FDA medical device recall by Vortex Surgical Inc., initiated 2025-11-19. It names one FDA 510(k) clearance: K220263. Product: Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe, Catalog Number VS0135.25;. Reason: Reason for the voluntary recall is some products in this lot are not passing through a 25ga cannula smoothly..

Recalling firm: Vortex Surgical Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-11-19
Firm location: Saint Charles, MO, United States

510(k) clearances named in this recall

1 on FDA's record

K220263 — Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical ChandeliersVortex Surgical, Inc.·cleared 2022-11-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.