Artoura Breast Tissue Expanders Reference Numbers:... recall (Mentor Texas, LP.)
Medical deviceClass IIOngoing
Summary: Mentor Texas, LP. is recalling 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.
What is being recalled
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
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
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.
How to tell if yours is affected
UDI(s): 10081317028182 10081317028205 10081317028212 10081317028229 10081317028236 10081317028281
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-1687-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | February 18, 2026 |
| Reported | April 8, 2026 |
| Company | Mentor Texas, LP. |
| Company location | Irving, TX, United States |
| Initiated by | Voluntary: Firm initiated |
More recalls from Mentor Texas, LP. · all medical device recalls · recalls from February 2026