YelloPort Elite Universal Seal. For use in laparoscopic procedures.

Class I - Dangerous

What Should You Do?

Check if you have this product:
All Lots; UDI/DI:05051986001562
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
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.

Company:: Surgical Innovations Ltd
Reason for Recall:: There is the potential that YelloPort Elite Universal Seals packaging may contain small holes which may affect the sterility of the product.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: completed

YelloPort Elite Universal Seal. For use in laparoscopic procedures.

All Lots; UDI/DI:05051986001562

Always verify recall information with the official FDA source:

FDA Recall Number: Z-1396-2022

Surgical Innovations

Class I - Dangerous

Optical Trocars sterility assurance can not be guaranteed

Mar 28, 2023 Other Medical Devices View Details →

Surgical Innovations

Class I - Dangerous

Optical Trocars sterility assurance can not be guaranteed

Mar 28, 2023 Other Medical Devices View Details →

Surgical Innovations

Class I - Dangerous

Laparoscopic devices have a sterile symbol included on labels but devices are non-sterile.

Jan 20, 2022 Other Medical Devices View Details →