FDA updates early alert for Resmed vents
By HME News Staff
Updated 10:43 AM CDT, Wed August 5, 2026
WASHINGTON – The U.S. Food and Drug Administration (FDA) has updated its early alert for certain Resmed Astral ventilators to a recall. “The affected products and recommendations for what to do with the devices have not changed,” the agency stated. “This recall involves correcting certain devices and does not involve removing them from where they are used or sold.” The FDA has identified the recall as the most serious type, with the potential to cause serious injury or death. The agency says it is aware that Resmed has issued a letter to affected customers recommending that certain Astral 100 and Astral 150 vents be corrected as soon as replacement parts become available. It says patients should not stop using the ventilators unless they are instructed by their clinician. The FDA issued its early alert on July 15, saying it was aware that Resmed had issued a voluntary Global Medical Devie Correction / Field Safety Notice for these vents built before October 2024 due to the potential of a component called a supercapacitor leaking over time. The leakage may damage internal parts and result in the vents incorrectly entering a protective safety state. Resmed has said it is taking a phased approach to address the issue, due to the limited availability of replacement parts. It says patients who may be at the highest risk if ventilation stops unexpectedly will be the first priority.
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