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Home › FDA recalls › Artoura Breast Tissue Expanders Reference Numbers: SDC-100H
CLASS II · ModerateFDA

Mentor Texas, LP. recalls Artoura Breast Tissue Expanders Reference Numbers: SDC-100H SDC-110H SDC-120H SDC-130H SD

📅 Feb 18, 2026 · 📍 Nationwide
Recalling company
Mentor Texas, LP.
Product
Artoura Breast Tissue Expanders Reference Numbers: SDC-100H SDC-110H SDC-120H SDC-130H SDC-135H SDC-140H SDC-150H SDC-155H Smooth High Profile Tissue Expander, 225cc, 300cc, 375cc, 475cc, 500cc, 600cc, 750cc, 850cc
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
UDI(s): 10081317028168 10081317028175 10081317028199 10081317028243 10081317028250 10081317028267 10081317028274 10081317028151
Company location
Irving, TX
Recall type
Voluntary: Firm initiated
Recall number
Z-1686-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-1686-2026 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.