Recall archive / FDA device enforcement
AirFit N10 Nasal Masks and User Guide — FDA record Z-0536-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Nov 20, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- AirFit N10 Nasal Masks and User Guide
- Reason
- 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
- Classification
- Class I
- Recalling firm
- ResMed Ltd.
- Quantity
- 199,796
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0536-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
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
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Dec 27, 2023
- Recall initiation date
- Nov 20, 2023
- Center classification date
- Dec 21, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.