FDANovember 20, 2023device
AirFit F20 Full Face Mask and User Guide
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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
What to do
FDA enforcement status: Ongoing
Brands named
resmed
UPCs
619498634019619498634484619498634460619498634002619498634453619498634033619498634569619498634477619498634026619498634040619498634491619498634507
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAAirTouch F20 Full Face Mask and User Guide2023-11-20
- FDAAirFit N10 Nasal Masks and User Guide2023-11-20
- FDAAirFit N20 Nasal Mask and User Guide2023-11-20
- FDAAirTouch N20 Nasal Mask and User Guide2023-11-20
- FDAAirFit F30 Full Face Mask and User Guide2023-11-20
- FDAAirFit F30i Full Face Mask and User Guide2023-11-20
- FDAAstral 100 and Astral 150 ventilators2023-09-13
- FDAResMed Stellar, Non-invasive/invasive ventilators, Model: 100, 1502019-12-12
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