FDA Medical devices recall ·
Artoura Breast Tissue Expanders Reference Numbers: SDC-100UH SDC-110UH… recall
- Recall number
- Z-1687-2026
- Date
- (initiated February 18, 2026)
- Company / brand
- Mentor Texas, LP.
3041 Skyway Cir N, Irving, TX, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI(s): 10081317028182 10081317028205 10081317028212 10081317028229 10081317028236 10081317028281
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.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1687-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.