Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1685-2026 — 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,

U.S. FDA — Device Enforcement · United States · 2026-02-18 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1685-2026
Date of alert
2026-02-18
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Mentor Texas, LP.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00081317009450
Reported risk: Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.