AirFit F30i Full Face Mask and User Guide — Class I medical device recall Z-0542-2024
Ongoing recall by ResMed Ltd., reported 2023-12-27, distributed nationwide. Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic inte
| Recall number | Z-0542-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | ResMed Ltd., Bella Vista, N/A, Australia |
| Recall initiated | 2023-11-20 |
| Classified | 2023-12-21 |
| Reported by FDA | 2023-12-27 |
| Distributed | Nationwide (US) |
| Quantity | 2,037,323 |
| UPC / GTIN / UDI-DI | 00619498633005, 00619498633012, 00619498633050, 00619498633067, 00619498633074, 00619498633081, 00619498633104, 00619498633111, 00619498633128, 00619498633135, 00619498633142, 00619498633302, 00619498633319, 00619498633326, 00619498633333, 00619498633340, 00619498633364, 00619498633371, 00619498633388, 00619498633395, 00619498633401 |
Product
AirFit F30i 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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0542-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.