🔍 RecallPedia

Artoura Breast Tissue Expanders Reference Numbers: SDC-100UH SDC-110UH SDC-120UH SDC-130UH SDC-135UH SDC-140UH Smooth Ultra High Profile Tissue Expander, 350cc, 455cc, 535cc, 650cc, 700cc, 850cc

Class I - Dangerous
🏥 Medical Devices Recalled: February 18, 2026 Mentor Texas Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    UDI(s): 10081317028182 10081317028205 10081317028212 10081317028229 10081317028236 10081317028281
  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:

Artoura Breast Tissue Expanders Reference Numbers: SDC-100UH SDC-110UH SDC-120UH SDC-130UH SDC-135UH SDC-140UH Smooth Ultra High Profile Tissue Expander, 350cc, 455cc, 535cc, 650cc, 700cc, 850cc

Product Codes/Lot Numbers:

UDI(s): 10081317028182 10081317028205 10081317028212 10081317028229 10081317028236 10081317028281

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1687-2026

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