Vortex Surgical I2 Injection Kit, VS0500

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Pouch UDI 810123480920 Box UDI 810123481330 Lot 2411012
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Vortex Surgical Inc.
Reason for Recall:
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Vortex Surgical I2 Injection Kit, VS0500

Product Codes/Lot Numbers:

Pouch UDI 810123480920 Box UDI 810123481330 Lot 2411012

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1252-2026

Related Recalls

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.

Dec 16, 2025 Surgical Instruments Nationwide View Details →