CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-113TH, SCPX-123TH, SCPX-140TH, SCPX-146TH Smooth Tall Height Tissue Expander, 350cc, 450cc, 650cc, 750cc

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    UDI(s):10081317028427 10081317028434 10081317028458 10081317028465
  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:
Mentor Texas, LP.
Reason for Recall:
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-113TH, SCPX-123TH, SCPX-140TH, SCPX-146TH Smooth Tall Height Tissue Expander, 350cc, 450cc, 650cc, 750cc

Product Codes/Lot Numbers:

UDI(s):10081317028427 10081317028434 10081317028458 10081317028465

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1684-2026

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