ResMed Ltd. recalls AirFit N10 Nasal Masks and User Guide

Recall date

November 20, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0536-2024

FDA classification

Class I

Brand / firm

ResMed Ltd.

Sold / distributed

US nationwide distribution including Puerto Rico, Guam, and Virgin Islands. OUS (foreign) countries of: AE, AR, AT, AU, BB, BD, BE, BG, BH, BM, BR, CA, CH, CL, CN, CO, CW, CY, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FO, FR, GB, GF, GG, GL, GP, GR, GT, GY, HK, HN, HR, HU, ID, IE, IL, IM, IN, IR, IS,…

Why it was recalled

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

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

AirFit N10 Nasal Masks and User Guide