Recall Z-1683-2026— Mentor Texas, LP.

Name: FDA recall Z-1683-2026
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: K241918. Product: CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-107MH, SCPX-117MH,SCPX-127MH, SCPX-135MH, SCPX-146MH, SCPX-156MH Smooth Medium Height Tissue Expander, 275cc, 350cc, 450cc, 550cc, 650cc, 800cc. 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

K241918 — MENTOR CPX4 PLUS Enhance Breast Tissue ExpanderMentor Worldwide, LLC·cleared 2024-08-02

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

CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-107MH, SCPX-117MH,SCPX-127MH, SCPX-135MH, SCPX-146MH, SCPX-156MH Smooth Medium Height Tissue Expander, 275cc, 350cc, 450cc, 550cc, 650cc, 800cc

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.