Home / Recalls / Mentor Texas, LP. / Z-1685-2026

Z-1685-2026 Class II Ongoing

Recalled by Mentor Texas, LP. — Irving, TX

Recall Details

Product Type
Devices
Report Date
April 8, 2026
Initiation Date
February 18, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity

Product 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 for Recall

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

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.

Code Information

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

Other recalls by Mentor Texas, LP.

  • Z-1681-2026 Class II — CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: 354-9113, (February 18, 2026)
  • Z-1684-2026 Class II — CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-113TH (February 18, 2026)
  • Z-1687-2026 Class II — Artoura Breast Tissue Expanders Reference Numbers: SDC-100UH SDC-110UH SDC-120U (February 18, 2026)
  • Z-1682-2026 Class II — CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-157LH (February 18, 2026)
  • Z-1686-2026 Class II — Artoura Breast Tissue Expanders Reference Numbers: SDC-100H SDC-110H SDC-120H S (February 18, 2026)
  • Z-1683-2026 Class II — CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-107MH (February 18, 2026)
  • Z-0367-2022 Class II — MENTOR Saline-Filled Breast Implants are constructed from room temperature vulc (September 30, 2021)
  • Z-2070-2017 Class II — Mentor Smooth Round SPECTRUM Post- Operatively Adjustable Saline Breast Implant (March 27, 2017)
  • Z-2781-2016 Class II — CPX4 Breast Tissue Expander 650 cc : Product Usage: Tissue expanders can be u (August 9, 2016)
  • Z-2747-2016 Class II — MENTOR 2" Tall Height TE With Sutures 350cc PN: 354-9312 The MENTOR CPX4 and (August 9, 2016)