HIGH

Vortex Surgical Recalls Laser Probe Due to Smooth Passage Issues

Vortex Surgical recalled 221 units of the 25ga Illuminated Flex-Tip Laser Probe on November 19, 2025. The product does not pass through a 25ga cannula smoothly, which poses a high hazard risk. Patients and healthcare providers must stop using the device immediately and follow recall instructions.

Quick Facts at a Glance

Recall Date
November 19, 2025
Hazard Level
HIGH
Brand
Vortex Surgical
Category
Health & Personal Care
Sold At
Multiple Retailers
At-Risk Groups
GENERAL

Hazard Information

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

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Vortex Surgical Inc. or your healthcare provider for instructions. Notification method: E-Mail

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About This Product

The Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe is a medical device used in surgical procedures. It is designed to assist in precise laser applications.

Why This Is Dangerous

The defect involves the probe's inability to pass smoothly through a 25ga cannula, which could hinder surgical procedures and increase the risk of complications.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Consumers should cease using the device immediately to avoid potential surgical complications. This recall may cause inconvenience for healthcare providers needing to replace these devices.

Practical Guidance

How to identify if yours is affected

  1. Check the catalog number on the product packaging.
  2. Verify the lot number against the recall notice.
  3. Contact Vortex Surgical if uncertain about the product's status.

Where to find product info

The catalog number and lot number can typically be found on the product box or pouch.

What timeline to expect

Expect the refund process to take approximately 4-6 weeks after the product is returned.

If the manufacturer is unresponsive

  • Document all attempts to contact Vortex Surgical.
  • Consider filing a complaint with the FDA if unresponsive.

How to prevent similar issues

  • Always verify product recalls before use.
  • Look for FDA approval and certification when purchasing medical devices.
  • Consult healthcare professionals regarding device safety.

Documentation advice

Keep records of your correspondence with Vortex Surgical and any receipts for the device.

Product Details

The recalled product is the Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe, Catalog Number VS0135.25. It has been distributed in the US and Japan and falls under Class II classification.

Key Facts

  • 221 units recalled
  • Distributed in the US and Japan
  • Class II medical device
  • Immediate stop-use required

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
UDI: Box (01)00810123483617(17)281001(10)2509040
Pouch (01)00810123483549(17)281001(10)2509040. Lot Number 2509040
Report Date
January 7, 2026
Recall Status
ACTIVE

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