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Home › FDA recalls › CPX 4 US Breast Tissue Expanders with Suture Tabs Reference
CLASS II · ModerateFDA

Mentor Texas, LP. recalls CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-157LH Smooth L

📅 Feb 18, 2026 · 📍 Nationwide
Recalling company
Mentor Texas, LP.
Product
CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-157LH Smooth Low Height Tissue Expander, 650cc
Reason
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Feb 18, 2026
Reported
Apr 8, 2026
Distribution
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.
Status
Ongoing
Lot / codes
10081317028335
Company location
Irving, TX
Recall type
Voluntary: Firm initiated
Recall number
Z-1682-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-1682-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.