FDA Issues Class I Recall for ResMed Astral 100/150 Ventilators

The FDA has designated an issue with certain ResMed Astral 100 and 150 ventilators as a Class I recall, the most serious type. A leaking internal supercapacitor can damage the circuit board, potentially causing the device to fail and interrupt ventilation therapy. This defect poses a risk of serious adverse health consequences or death. Healthcare providers must acknowledge a correction form and reinforce safety measures, including backup ventilation.