ResMed Ltd.: Medical Device Recall in 2023 - (Recall #: Z-0541-2024)

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 F30 Full Face Mask and User Guide

Product Classification:

Class I

Date Initiated: November 20, 2023

Date Posted: December 27, 2023

Recall Number: Z-0541-2024

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: 2,660,776

Code Information:

All mask lots used with User Guide 638234/version 2020-07, and prior. UDI-DI/GTIN: 619498641048, 619498641000, 619498641017, 619498641406, 619498641055, 619498641116, 619498641277, 619498641109, 619498641154, 619498641260, 619498641147

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