FDAHealthFebruary 18, 2026
Mentor Texas, LP. — CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-107MH, SCPX-117MH,SCPX-127MH, SCPX-135MH, SCPX-146MH, SCPX-156MH Smooth Medium Height Tissue Expander,
⚠️ 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
- CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-107MH, SCPX-117MH,SCPX-127MH, SCPX-135MH, SCPX-146MH, SCPX-156MH Smooth Medium Height Tissue Expander, 275cc, 350cc, 450cc, 550cc, 650cc, 800cc
- Brand
- Mentor Texas, LP.
- Lot code
- 10081317028359 10081317028366 10081317028373 10081317028380 10081317028397 10081317028403
Additional details
10081317028359 10081317028366 10081317028373 10081317028380 10081317028397 10081317028403
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated
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