BEUDAMED
    FDA Enforcement Class II Ongoing

    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,

    Recall: Z-1685-2026 · Reported April 8, 2026

    Enforcement

    Recall Number
    Z-1685-2026
    Event ID
    98482
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Mentor Texas, LP.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 8, 2026
    Initiation Date
    February 18, 2026
    Classification Date
    March 27, 2026
    Address
    3041 Skyway Cir N, Irving, TX, 75038-3524, United States

    Description

    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,

    Reason

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

    Code Info

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

    Distribution

    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.