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

Recall Z-2454-2019 — Natrelle and McGhan Silicone-Filled Breast Implant BioCell Round Moderate Profile, Sterile, for the following style numbers: Style 110:110-090, 110-120, 110-150, 110-180, 110-210, 110-240, 110-270, 110-300, 110-330, 110-360, 110-390, 110-420, 110-450, 110-480, 110-510; Style 115 :1

U.S. FDA — Device Enforcement · United States · 2019-07-24 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2454-2019
Date of alert
2019-07-24
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Allergan PLC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10888628002159
Reported risk: The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.
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.