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Recall Observatory FDA recall evidence

Device 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

Z-1687-2026

February 18, 2026

Class II

Product summary

Firm
Mentor Texas, LP.
Event
Event 98482
Status
Ongoing
Classification
Class II
Quantity
Unavailable
Official record key
device-enforcement:Z-1687-2026

Official wording

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

Code information: UDI(s): 10081317028182 10081317028205 10081317028212 10081317028229 10081317028236 10081317028281

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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