FDASeptember 13, 2023device
Astral 100 and Astral 150 ventilators
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
If ventilator is on internal battery, not intended to serve as a primary power source, low/critically low battery alarms will sound, but a fault leads to sudden power loss. If power fails, then ventilation stops and a Total Power Failure (TPF) alarm should sound, but it's powered by a supercapacitor, which degrades over time, which may cause TPF alarm to sound for less than 2 minutes or not at all
What to do
FDA enforcement status: Ongoing
Brands named
resmed
UPCs
221512345670061949800325900619498003266
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
- FDAAirFit F20 Full Face Mask and User Guide2023-11-20
- FDAResMed Stellar, Non-invasive/invasive ventilators, Model: 100, 1502019-12-12
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