FDA Issues Class 1 Recall for ResMed Astral Home Ventilators, Advises Continued Use

The U.S. Food and Drug Administration issued an early alert on July 15 and later applied its most serious Class 1 recall to ResMed Astral 100 and Astral 150 home ventilators. The recall covers 168,069 devices built before October 2024 and identified by serial numbers below a specific threshold. A faulty supercapacitor can leak electrolyte, damaging the circuit‑board assembly and causing the ventilator to enter a fail‑safe state that stops breathing support during therapy or prevents start‑up in standby mode.

The agency reported five serious injuries and no deaths linked to the defect. Replacement circuit boards are in limited supply, prompting the FDA to instruct patients not to stop using the ventilators unless directed by a clinician and to keep a functional backup available. Providers are asked to verify the installed board rather than rely on the original build date. The recall affects users across the United States, the District of Columbia, Puerto Rico and other markets worldwide.