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ResMed Ltd. FDA Recalls
9 recalls on file across devices, 9 of them Class I and 9 still open. Matched by name to RMD.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that provides continuous or intermittent ventilatorClass IJun 25, 2026Due to a Supercapacitor electrolyte leakage on Printed Circu |
| AirTouch F20 Full Face Mask and User GuideClass INov 20, 2023Masks non-invasive interface for channeling airflow to patie |
| AirFit F30 Full Face Mask and User GuideClass INov 20, 2023Masks non-invasive interface for channeling airflow to patie |
| AirFit F30i Full Face Mask and User GuideClass INov 20, 2023Masks non-invasive interface for channeling airflow to patie |
| AirFit N10 Nasal Masks and User GuideClass INov 20, 2023Masks non-invasive interface for channeling airflow to patie |
| AirTouch N20 Nasal Mask and User GuideClass INov 20, 2023Masks non-invasive interface for channeling airflow to patie |
| AirFit F20 Full Face Mask and User GuideClass INov 20, 2023Masks non-invasive interface for channeling airflow to patie |
| AirFit N20 Nasal Mask and User GuideClass INov 20, 2023Masks non-invasive interface for channeling airflow to patie |
| Astral 100 and Astral 150 ventilatorsClass ISep 13, 2023If ventilator is on internal battery, not intended to serve |