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

Laser probes recalled because they may not pass smoothly through a cannula

Vortex Surgical is recalling 221 units of its 25ga Illuminated Flex-Tip Laser Probe because some products in the lot are not passing through a 25ga cannula smoothly.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: Scored 2 because the record cites a probe that does not pass smoothly through the cannula, with no stated consequence or reported harm.

Plain-English summary

The Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe, catalog number VS0135.25, is being recalled.

The reason given for the voluntary recall is that some products in the lot are not passing through a 25ga cannula smoothly.

The record lists 221 units, carrying box UDI (01)00810123483617 and pouch UDI (01)00810123483549, from lot 2509040. Distribution was in the United States and Japan. The FDA has classified the action as Class II.

The record describes a fit problem between the probe and the cannula and states no further consequence or reported injuries. Facilities should quarantine the affected lot and follow the firm's instructions.

The recalled product

Product
Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe, Catalog Number VS0135.25;
Manufacturer
Vortex Surgical Inc.
Category
Medical Device — Ophthalmic instrument
Hazard
  • fit-problem
  • cannula
  • ophthalmic

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.

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