Recall Z-1681-2026— Mentor Texas, LP.

Name: FDA recall Z-1681-2026
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: K130813. Product: CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: 354-9113, 3549313, 354-9314 SILTEX Low Height Tissue Expander Style (9100, 450cc), (9300, 450cc), (9300, 550cc). 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

K130813 — MENTOR CPX 4 BREAST TISSUE EXPANDERS AND MENTOR CPX 4 WITH SUTURE TABS BREAST TISSUE EXPANDERSMentor Corp.·cleared 2013-04-11

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: 354-9113, 3549313, 354-9314 SILTEX Low Height Tissue Expander Style (9100, 450cc), (9300, 450cc), (9300, 550cc)

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.