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

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

📅 Feb 18, 2026 · 📍 Nationwide
Recalling company
Mentor Texas, LP.
Product
Artoura Breast Tissue Expanders Reference Numbers: SDC-100UH SDC-110UH SDC-120UH SDC-130UH SDC-135UH SDC-140UH Smooth Ultra High Profile Tissue Expander, 350cc, 455cc, 535cc, 650cc, 700cc, 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): 10081317028182 10081317028205 10081317028212 10081317028229 10081317028236 10081317028281
Company location
Irving, TX
Recall type
Voluntary: Firm initiated
Recall number
Z-1687-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-1687-2026 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.