FDAHealthFebruary 18, 2026
Mentor Texas, LP. — CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: 354-9113, 3549313, 354-9314 SILTEX Low Height Tissue Expander Style (9100, 450cc), (9300, 450cc), (9300, 550c
⚠️ 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: 354-9113, 3549313, 354-9314 SILTEX Low Height Tissue Expander Style (9100, 450cc), (9300, 450cc), (9300, 550cc)
- Brand
- Mentor Texas, LP.
- Lot code
- 00081317006671 00081317006794 00081317006800
Additional details
00081317006671 00081317006794 00081317006800
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated
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