The Recall Desk
HighFDA (Devices)·Z-1004-2026·Announced 2026-01-07

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

Pending LLM rewrite. Source: FDA_DEVICE Z-1004-2026.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

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

The recalled product

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

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

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

Distribution

Distribution scope not specified by the agency.