FDA Device recall Z-0539-2024
AirFit N20 Nasal Mask and User Guide
- FDA Device
- Class I
- ongoing
- Published 2023-12-27
On 2023-12-27 the FDA classified a Class I recall of AirFit N20 Nasal Mask and User Guide by Resmed, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0539-2024 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2023-11-20 |
| Published | 2023-12-27 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Resmed |
| Distribution | US |
Product
AirFit N20 Nasal Mask 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
Identifiers
| code_info | All mask lots used with User Guide 638218/version 2020-02, 638243/version 2020-06, and prior. UDI-DI/GTIN: 61949863501…All mask lots used with User Guide 638218/version 2020-02, 638243/version 2020-06, and prior. UDI-DI/GTIN: 619498635016, 619498635054, 619498635061, 619498635351, 619498635047, 619498635030, 619498635078, 619498635382, 619498635023, 619498635344, 619498635009, 619498635399, 619498635115, 619498635122, 619498635375, 619498635214, 619498635221, 619498635252, 619498635245, 619498635313, 619498635337, 619498635207, 619498635320, 619498635238, 619498635092, 619498635108, 619498635306, 619498635290, 619498635184, 619498635146, 619498635160, 619498635139, 619498635177, 619498635153 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0539-2024%22
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