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

Recall Z-0541-2024 — AirFit F30 Full Face Mask and User Guide

U.S. FDA — Device Enforcement · Australia · 2023-11-20 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0541-2024
Date of alert
2023-11-20
Country / jurisdiction
Australia
Risk level
Class I
Risk type
recall
Brand
ResMed Ltd.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
619498641048
Reported risk: Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical implants that interact with magnets, and metallic implants/objects containing ferromagnetic material so contraindications and warnings about safe distance to medical devices/implants are being updated for patients using masks or anyone in close physical contact
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.