Home / Recalls / Medical Devices
Mentor Texas, LP. recalls Artoura Breast Tissue Expanders Reference Numbers: SDC-100H SDC-110H SDC-120H SDC-130H SDC-135H SDC-140H SDC-150H SDC-1
Recalled April 8, 2026 · FDA recall Z-1686-2026 · 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-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
Manufacturer(s)
Mentor Texas, LP.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →