FDA Device recall Z-0542-2024
AirFit F30i 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 F30i 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-0542-2024 |
| 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 F30i 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 638225/version 2020-02, and prior. UDI-DI/GTIN: 619498633326, 619498633067, 6194986…All mask lots used with User Guide 638225/version 2020-02, and prior. UDI-DI/GTIN: 619498633326, 619498633067, 619498633012, 619498633340, 619498633302, 619498633333, 619498633050, 619498633319, 619498633005, 619498633135, 619498633128, 619498633364, 619498633388, 619498633371, 619498633401, 619498633395, 619498633104, 619498633142, 619498633111, 619498633081, 619498633074 |
|---|
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-0542-2024%22
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