ResMed Astral 100/150 Ventilators Recall
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ResMed Ltd. is recalling 168,069 Astral 100 and 150 ventilator devices worldwide due to a supercapacitor issue that may interrupt ventilation therapy.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 13, 2026 and geographically references Worldwide. Its severity classification of "high" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, medical-devices.
What Happened
ResMed Ltd. initiated a Class I recall due to a supercapacitor electrolyte leakage on the Printed Circuit Board Assembly (PCBA) that may damage the charger chip, causing a fail-safe state and interruption of ventilation therapy.
Which Products Are Affected
The recall affects Resmed Astral 100 and Resmed Astral 150 ventilator systems that provide continuous or intermittent ventilatory support for patients weighing more than 11 lb (5 kg). A total of 168,069 devices are affected globally. Affected units include:
- Catalog Number: Astral 100 (UDI-DI: 00619498003259), serial numbers < 22241890149; PCBA spare parts with characters 2 8 < 2707658 or box serial < 22241978070
- Catalog Number: Astral 150 (UDI-DI: 00619498270033), serial numbers < 22241440282; PCBA spare parts with characters 2 8 < 2707658 or box serial < 22241978070 Distribution includes U.S. nationwide and the countries of Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bhutan, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, French Guiana, French Polynesia, Germany, Great Britain, Greece, Guadeloupe, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Islamic Republic of Iran, Israel, Italy, Japan, Jordan, Kenya, Republic of Korea, Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Maldives, Malta, Martinique, Mauritius, Mexico, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Norway, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Saint Martin (French part), Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, Uruguay, and Viet Nam. Recall number Z-2735-2026.
What You Should Do
The recalling firm initiated the action via letter. Consumers with affected devices should follow instructions provided by ResMed Ltd.
Why This Matters
The Class I recall involves devices whose failure could interrupt mechanical ventilation therapy for patients requiring respiratory support.
Source
FDA recall Z-2735-2026, report date 20260805. https://www.fda.gov
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (2,209 characters here).
Similar severity timing
Same severity (high) notices issued closest in time to August 13, 2026.
Frequently Asked Questions
Common questions about this FDA recall.