BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated February 18, 2026

    Recall

    Recall Number
    Z-1685-2026
    Event Number
    98482
    FEI Number
    1000118360
    Product Code
    LCJ
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    February 18, 2026
    Posted
    March 27, 2026
    Address
    3041 Skyway Cir N, Mentor Texas, LP., Irving, TX, 75038-3524

    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.

    Action

    On March 2, 2026, Mentor Worldwide LLC issued a updated "Urgent Medical Device Recall (Removal). The initial notification was issued on February 18, 2026. Mentor is asking consignees to take the following actions: 1. Examine your inventory and quarantine immediately any affected products. 2. Please maintain a copy of the notice with the quarantined product. 3. Notify all personnel who need to be made aware of the recall. 4. Complete the Business Reply Form of this notice and fax 877-223-7559 or email [email protected] to Sedgwick within 3 business days. 5. If you require any assistance with returning product, please contact Sedgwick at 877-546-7680 and reference Event # 3910

    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.