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Recall Observatory FDA recall evidence

Device 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

Z-1686-2026

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-1686-2026

Official wording

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

Code information: UDI(s): 10081317028168 10081317028175 10081317028199 10081317028243 10081317028250 10081317028267 10081317028274 10081317028151

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.