Mentor Texas, LP. recalls Artoura Breast Tissue Expanders Reference Numbers: SDC-100UH SDC-110UH SDC-120UH SDC-130UH SDC-135UH SDC-140UH Smooth

Recalled April 8, 2026 · FDA recall Z-1687-2026 · Mentor Texas

Hazard

Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. · FDA Class II

Sold at

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.

Description

Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.

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

Manufacturer(s)

Mentor Texas, LP.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →