Home / Recalls / Mentor Texas, LP. / Z-1686-2026

Z-1686-2026 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: SDC-100H SDC-110H SDC-120H SDC-130H SDC-135H SDC-140H SDC-150H SDC-155H Smooth High Profile Tissue Expander, 225cc, 300cc, 375cc, 475cc, 500cc, 600cc, 750cc, 850cc

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): 10081317028168 10081317028175 10081317028199 10081317028243 10081317028250 10081317028267 10081317028274 10081317028151

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-1685-2026 Class II — Artoura Breast Tissue Expanders Reference Numbers: TEXP110RH TEXP120RH TEXP120R (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)