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Recall Observatory FDA recall evidence

Device product

Artoura Breast Tissue Expanders Reference Numbers: TEXP110RH TEXP120RH TEXP120RUH TEXP130RH TEXP135RH TEXP140RH TEXP150RH Textured, High & Ultra High Profile, Integral Injection Dome, 300cc, 375cc, 535cc, 475cc, 500cc, 600cc, 750cc,

Z-1685-2026

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-1685-2026

Official wording

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

Code information: UDI(s): 00081317009450 00081317009467 00081317009542 00081317009474 00081317009481 00081317009498 00081317009504

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.