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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

Class II
Recalling firm
Mentor Texas, LP.
Reason for recall
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
Distribution pattern
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.
State
TX
Status
Ongoing
Recall number
Z-1687-2026
Recall initiated
February 18, 2026
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