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Recall Observatory FDA recall evidence

Device product

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

Z-1004-2026

November 19, 2025

Class II

Product summary

Firm
Vortex Surgical Inc.
Event
Event 98032
Status
Ongoing
Classification
Class II
Quantity
221 units
Official record key
device-enforcement:Z-1004-2026

Official wording

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

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

Distribution pattern: US and Japan

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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