FDA recall, , High risk
ResMed Astral 100 and 150 Ventilators
The Resmed Astral ventilator system can fail due to electrolyte leakage, interrupting ventilation therapy.
Summary by Recall Canary from the FDA notice
What happened
ResMed Ltd. is recalling the ResMed Astral 100/150 ventilator system, which provides continuous or intermittent ventilatory support for patients weighing more than 11lb (5kg) who require mechanical ventilation, due to a Supercapacitor electrolyte leakage on Printed Circuit Board Assembly (PCBA) that may damage the charger chip, causing fail-safe state and interruption of ventilation therapy. The recall, which began on June 25, 2026, involves 168,069 devices globally.
The recall was added to the FDA's Enforcement Report on July 28, 2026, and included in the FDA's weekly enforcement report on August 5, 2026. Distribution is worldwide, including nationwide in the U.S. and in numerous other countries.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI is listed.
A UDI-DI is the device identifier printed with the barcode on the device label.
Resmed Astral 100/150 Resmed Astral 100/50
- UDI-DI
- 00619498003259
- 22241890149
- 22241978070
- 00619498270033
- 22241440282
Recall details
- Company began the recall
- Sold in
Worldwide - U.S. Nationwide distribution including in the states of Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, PR, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia, and Wyoming. 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.
- Company
- ResMed Ltd.Bella Vista, Australia
- Hazard
- Device defect
- Risk
High risk
There is a reasonable chance that using it could cause serious health problems or death.
FDA Class I recall · How risk is rated
- Event ID
- 99304
- Recall number
- Z-2735-2026
- Quantity recalled
- 168,069 devices globally
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
