FDA Device recall Z-0537-2024
AirFit F20 Full Face 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 F20 Full Face 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-0537-2024 |
| 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 F20 Full Face 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 638220/version 2020-02, 638238/version 2020-12, 638221/version 2020-01, and prior.…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 |
|---|
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-0537-2024%22
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