FDAHealthFebruary 18, 2026
Mentor Texas, LP. — 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, 650
⚠️ Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- February 18, 2026
Worldwide distribution - US Nationwide and the countries of Canada, Albania, Australia, Austria, Belgium, Bulgaria, Croatia, Denmark, Finland, France, Germany, Iceland, Ireland, Italy, Norway, Pakistan, Poland, Romania, Saudi Arabia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Taiwan, United Kingdom, Czech Republic.
What's affected?
- Product
- 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
- Brand
- Mentor Texas, LP.
- Lot code
- UDI(s): 10081317028182 10081317028205 10081317028212 10081317028229 10081317028236 10081317028281
Additional details
UDI(s): 10081317028182 10081317028205 10081317028212 10081317028229 10081317028236 10081317028281
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated
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