HIGH

Vortex Surgical Recalls Injection Cannula Due to Infection Risk

Vortex Surgical recalled 14,789 units of its 25GA Subretinal Injection Cannula on December 16, 2025, due to a compromised sterile barrier. The recall affects devices distributed worldwide, including 8,651 units in the U.S. The issue may lead to bioburden contamination and potential infection.

Quick Facts at a Glance

Recall Date
December 16, 2025
Hazard Level
HIGH
Brand
Vortex Surgical
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.

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: Letter

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Product Details

The recalled product is the 25GA Subretinal Injection Cannula, catalog number VS0220.25. The recall includes lots identified through the manufacturer's notification letter.

The Hazard

Voids in the seal of Tyvek pouches may compromise the sterile barrier of the cannula. This defect increases the risk of bioburden contamination, which could lead to serious infections.

What to Do

Stop using the affected cannulas immediately. Follow the recall instructions provided by Vortex Surgical and contact your healthcare provider for further guidance.

Contact Information

For additional information, contact Vortex Surgical Inc. or your healthcare provider. The recall notice is available at the FDA website.

Key Facts

  • Recall Date: December 16, 2025
  • Report Date: February 11, 2026
  • Quantity Recalled: 14,789 units
  • Distribution: Worldwide including the U.S. and multiple countries
  • Hazard: Potential bioburden contamination

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 TypeInjection Cannula
Sold At
Multiple Retailers

Product Details

Model Numbers
Pouch UDI 810123480418 Box UDI 810123480692 Lot 2410043
Affected States
ALL
Report Date
February 11, 2026
Recall Status
ACTIVE

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