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

Recall Z-1687-2026 — 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

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-1687-2026
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)
10081317028182
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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