FDAFDA · Food and drugs·Recall number Z-1685-2026
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,
Published April 8, 2026 · Recall initiated: February 18, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Mentor Texas, LP.
- Distributor
- 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.
- Lot
- UDI(s): 00081317009450 00081317009467 00081317009542 00081317009474 00081317009481 00081317009498 00081317009504
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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