ResMed Ltd.: Medical Device Recall in 2023 - (Recall #: Z-0536-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

AirFit N10 Nasal Masks and User Guide

Product Classification:

Class I

Date Initiated: November 20, 2023

Date Posted: December 27, 2023

Recall Number: Z-0536-2024

Event ID: 93499

Reason for Recall:

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

Status: Ongoing

Product Quantity: 199,796

Code Information:

All mask lots used with User Guide 628153/version 2020-07, and prior. UDI-DI/GTIN: 619498632008, 619498632893, 619498632060, 619498632077, 619498632299, 619498632015, 619498632084, 619498632022, 619498632237, 619498632190, 619498632213, 619498632220, 619498632183, 619498632206, 619498632268, 619498632244, 619498632114, 619498632251, 619498632091, 619498632107, 619498632152, 619498632121, 619498632138, 619498632275, 619498632169, 619498632145, 619498632176

Distribution Pattern:

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, IT, JE, JO, JP, KE, KG, KR, KW, LB, LK, LT, LV, LY, MA, MC, MM, MQ, MT, MU, MV, MX, MY, NA, NC, NG, NL, NO, NP, NZ, OM, PA, PE, PF, PH, PK, PL, PM, PT, QA, RE, RO, RS, RU, SA, SD, SE, SG, SI, SK, SV, TH, TN, TR, TT, TW, UY, VE, VN, WF, YT, ZA

Voluntary or Mandated:

Voluntary: Firm initiated