Recall
FDAHealthFebruary 18, 2026

Mentor Texas, LP. — CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-157LH Smooth Low Height Tissue Expander, 650cc

⚠️ 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-157LH Smooth Low Height Tissue Expander, 650cc
Lot code
10081317028335

Additional details

10081317028335

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated

View original FDA notice →

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