Titan Touch Scro Zero Ang 22cm, Catalog Number ES29222400; inflatable penile Prosthesis

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    UDI/DI 05708932539203, Lot Numbers: 8806758, 8806757
  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:
Coloplast Manufacturing US, LLC
Reason for Recall:
A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to inflate and deflate the penile prosthesis.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Titan Touch Scro Zero Ang 22cm, Catalog Number ES29222400; inflatable penile Prosthesis

Product Codes/Lot Numbers:

UDI/DI 05708932539203, Lot Numbers: 8806758, 8806757

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1371-2023

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