Z-0537-2024 Class I Ongoing
Recalled by ResMed Ltd.
— Bella Vista, N/A
FDA device recall Z-0537-2024 was initiated by ResMed Ltd. on Nov 20, 2023 and is designated Class I. 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… The recall status is ongoing. Affected quantity: 11,885,039.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 27, 2023
- Initiation Date
- Nov 20, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11,885,039
Product Description
AirFit F20 Full Face Mask and User Guide
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
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
Code Information
All mask lots used with User Guide 638220/version 2020-02, 638238/version 2020-12, 638221/version 2020-01, and prior. UDI-DI/GTIN: 619498634019, 619498634484, 619498634460, 619498634002, 619498634453, 619498634033, 619498634569, 619498634477, 619498634026, 619498634040, 619498634491, 619498634507, 619498634521, 619498634538, 619498640065, 619498640072, 619498634064, 619498640096, 619498634316, 619498640058, 619498634118, 619498640119, 619498634071, 619498634248, 619498634217, 619498634224, 619498634330, 619498634200, 619498634347, 619498634323, 619498634309, 619498634255, 619498634231, 619498634279, 619498634286, 619498634262, 619498634057, 619498634293, 619498634095, 619498634088, 619498634361, 619498634378, 619498634354, 619498640218, 619498640201, 619498640225, 619498634132, 619498634187, 619498634163, 619498634101, 619498634156, 619498634125, 619498634170, 619498640089, 619498640140, 619498634149, 619498640102, 619498640126, 619498640133, 619498634194
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0537-2024
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026
These dates say when openFDA published the data file and when RegDataLab last loaded it. FDA may have changed the recall since.