The Component Failure Behind the Classification
Federal regulators have applied their most serious recall designation to a ventilator used in homes, hospitals, and portable settings, and the accompanying instruction is the opposite of what most people expect from a recall. Do not stop using the device.
The FDA device recall database lists a Class 1 designation for ResMed Astral 100 and Astral 150 ventilators under recall number Z-2735-2026, initiated by the firm on June 25, 2026, and posted July 28. The record covers 168,069 devices globally, with U.S. distribution across 49 states, the District of Columbia, and Puerto Rico.
The failure mechanism is a supercapacitor inside the unit that may leak electrolyte over time. The leakage can damage circuitry on the printed circuit board assembly and push the ventilator into a fail-safe state.
If that happens during therapy, ventilation stops. A maximum-volume alarm sounds, the screen may display therapy alarms and a red safety system fault message, and pressing the vent stop button shows System Fault 140. If it happens in standby, the alarm sounds but therapy will not start when initiated. In both scenarios the device can no longer deliver breath.
FDA had flagged the problem earlier through an early alert on July 15. As of June 23, the agency reported five serious injuries and no deaths associated with the issue.
A Correction, Not a Removal
Class 1 is the FDA's designation for situations in which use of the product carries a reasonable probability of serious injury or death. It is not, by itself, an instruction to return anything.
This action is a correction rather than a removal, and the distinction is doing real work here. For a patient who cannot breathe independently, taking away a functioning ventilator with no replacement available is more dangerous than continuing to use one with a known failure mode alongside monitoring and backup equipment.
FDA stated that patients should "NOT stop using the ventilator unless they are instructed by their clinician." The manufacturer's correction notice tells providers to "do not remove an affected ventilator from use unless an alternative is immediately available."
Replacement circuit boards are in short supply. The recall record states that immediate correction of all affected units is not feasible because of limited availability, which is why an interim guidance framework exists at all. Affected units are identified by serial number thresholds and by whether the currently installed main board is one of the affected boards. Ventilators fitted with an unaffected board are not implicated.
Households can find the serial number on the device label and confirm status through their equipment supplier or ResMed representative. FDA maintains a general explainer on what a medical device recall means.
Backup Equipment and the Caregiver Burden
The practical weight of this recall falls on families and home care staff, not on hospital biomedical departments.
The interim guidance asks that ventilator-dependent patients be appropriately monitored, that caregivers be trained and confident responding to alarms and emergencies, and that alternative ventilation equipment be functional, regularly checked, and immediately available. In a home setting, that translates into concrete obligations: a working manual resuscitator bag within reach, a tested spare device where one has been provided, and a caregiver who has actually practiced the response rather than read about it.
That is a meaningful ask. Home ventilation is often managed by a spouse, an adult child, or a rotating shift of paid aides. Alarm response training is not universal, and equipment checks are easy to defer.
Families should not attempt to inspect or open the device. The relevant action is confirming affected status, confirming that backup equipment is present and functional, and confirming that everyone who spends time alone with the patient knows what the maximum-volume alarm means and what to do next.
Patients should continue therapy unless directed otherwise by their treating clinician. Anyone whose ventilator becomes inoperable should have it removed from use and replaced with an appropriate alternative immediately.
Supply Constraints Reaching New Patients
There is a second-order effect worth naming. ResMed has told providers to expect supply constraints affecting availability of new Astral ventilators, and has recommended that clinicians prioritize alternative ventilator options for patients starting therapy, according to reporting by MedTech Dive.
The company also advised providers with devices beyond the expected eight-year service life to consider transitioning those patients to alternative ventilators.
That guidance ripples outward. A patient with amyotrophic lateral sclerosis, muscular dystrophy, spinal cord injury, or advanced chronic obstructive pulmonary disease who is being set up on home ventilation this summer may be routed to a different platform than their care team originally planned. Durable medical equipment suppliers absorbing both an inspection backlog and a supply squeeze may see turnaround times lengthen.
Households facing delays should raise it with the prescribing pulmonologist rather than the supplier alone, since clinical prioritization is what moves a case up the queue.
This is also not the first Class 1 action involving this component in these devices. FDA records show an earlier Class 1 recall of Astral 100 and 150 ventilators, recall number Z-0111-2024, initiated in September 2023 and still listed as open, concerning supercapacitor degradation that could shorten or silence the total power failure alarm.
Inspection Tiers and the Dates Ahead
The correction plan runs on a risk-tiered schedule. Providers were asked to evaluate affected patients by clinical risk category and to arrange inspections following a phased strategy, returning units to an authorized service center as needed. Patients who cannot breathe independently sit at the front of that queue.
Healthcare providers and distributors were asked to return an acknowledgment form by July 31, 2026, and to distribute the correction notice and patient letters immediately. The recall remains listed as open and classified, meaning not all affected products have been corrected.
The next milestones to watch are the pace of replacement board supply, any expansion of affected serial numbers, and whether the reported injury count changes as facilities complete their reviews. FDA has indicated it continues to evaluate the issue and that additional corrective actions may follow.
A known component failure can silently disable ventilation on a large installed base of devices. The people most affected are ventilator-dependent patients at home and the family members responsible for them overnight. The reasonable action is confirming affected status and confirming that functional backup ventilation is within arm's reach. The central uncertainty is how long correction will take given parts scarcity. MedicalDaily will report changes to the recall record or FDA guidance.
Frequently Asked Questions
Which devices are affected? Certain ResMed Astral 100 and Astral 150 ventilators, plus certain printed circuit board spare parts, identified by serial number thresholds. Units fitted with an unaffected main board are not implicated.
Should patients stop using the ventilator? No. FDA states patients should not stop using the device unless instructed by their clinician. An affected ventilator should only be removed from use when an alternative is immediately available.
What does a Class 1 recall mean? It is FDA's most serious classification, used when product use carries a reasonable probability of serious injury or death. It does not automatically mean the product must be returned.
What happens if the fault occurs? The ventilator enters a fail-safe state and stops delivering therapy. A maximum-volume alarm sounds and the screen may show a red safety system fault message.
Has anyone been hurt? FDA reported five serious injuries and no deaths associated with the issue as of June 23, 2026.
What should caregivers do right now? Confirm whether the device is affected through the supplier or manufacturer, verify that backup ventilation equipment is present and working, and make sure everyone caring for the patient can respond to alarms.
Why are repairs delayed? Replacement circuit boards are in limited supply, so all affected units cannot be corrected immediately. Inspections are being prioritized by clinical risk category.
