Recall Z-1687-2026— Mentor Texas, LP.

Name: FDA recall Z-1687-2026
Creator: U.S. Food and Drug Administration
Published: 2026-02-18

Class II · Ongoing

Class II FDA medical device recall by Mentor Texas, LP., initiated 2026-02-18. It names one FDA 510(k) clearance: K161176. Product: Artoura Breast Tissue Expanders Reference Numbers: SDC-100UH SDC-110UH SDC-120UH SDC-130UH SDC-135UH SDC-140UH Smooth Ultra High Profile Tissue Expander, 350cc, 455cc, 535cc, 650cc, 700cc, 850cc. Reason: Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break..

Recalling firm: Mentor Texas, LP.
Classification: Class II
Status: Ongoing
Initiated: 2026-02-18
Firm location: Irving, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K161176 — ARTOURA Breast Tissue Expanders with Smooth SurfaceMentor Worldwide, LLC·cleared 2016-05-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Artoura Breast Tissue Expanders Reference Numbers: SDC-100UH SDC-110UH SDC-120UH SDC-130UH SDC-135UH SDC-140UH Smooth Ultra High Profile Tissue Expander, 350cc, 455cc, 535cc, 650cc, 700cc, 850cc

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.