Z-2735-2026Class I

Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that provides continuous or intermittent...

Name: Z-2735-2026 Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that provides continuous or intermittent...
Creator: ResMed Ltd.
Published: 2026-06-25
License: https://open.fda.gov/license/

ResMed Corp / initiated 2026-06-25 / Open, Classified / root cause: design

FDA source

ResMed Ltd. began a recall of Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that provides continuous or intermittent ventilatory support for patients weighing more than... on 2026-06-25. FDA classified it as Class I and gives the reason as "Due to a Supercapacitor electrolyte leakage on Printed Circuit Board Assembly (PCBA) may damage the charger chip, causing fail-safe state and interruption of ventilation therapy". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2735-2026
Classification: Class I
Status: Open, Classified
Initiated: 2026-06-25
Posted: 2026-07-28
Recalling firm: ResMed Corp
Product: Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that provides continuous or intermittent ventilatory support for patients weighing more than 11lb (5kg) who require mechanical ventilation.
Product code: CBK Ventilator, Continuous, Facility Use
Reason for recall: Due to a Supercapacitor electrolyte leakage on Printed Circuit Board Assembly (PCBA) may damage the charger chip, causing fail-safe state and interruption of ventilation therapy.
Root cause tag: design
FDA root cause: Component design/selection
Action: ResMed Urgent Medical Device Correction Astral 100/150 Ventilators Issue Identified: On June 25, 2026, ResMed notified customers via Salesforce of an urgent medical device correction involving a subset of Astral 100 and Astral 150 ventilators. An internal supercapacitor may leak electrolyte over time, potentially damaging the printed circuit board assembly (PCBA) and causing the ventilator to enter a fail-safe state. Interim Guidance: Due to limited PCBA replacement availability, immediate correction of all affected units is not feasible. Physicians and patients are advised to follow Astral 100/150 User and Clinical Guides, including recommendations on monitoring, emergency preparedness, caregiver training, and backup ventilation. Required Actions for Healthcare Providers and Distributors: Acknowledge: Complete and return the acknowledgment form by July 31, 2026. Notify: Distribute the correction notice and accompanying letters to all relevant healthcare professionals, patients, and caregivers immediately. Reinforce Safety Measures: Ensure ventilator-dependent patients are monitored, caregivers are trained in alarm response and emergency procedures, and backup ventilation equipment is functional and readily available. Device Management: Do not remove an affected ventilator from use unless an alternative is immediately available. Replace inoperable units promptly; patients should continue therapy unless directed otherwise by their clinician. Risk Assessment: Evaluate affected patients by clinical risk category (Tier 1, 2, or 3) per Appendix A. Arrange Inspection: Schedule ventilator inspections per the Phase 1 Inspection and Correction Strategy in Appendix A, returning units to an authorized service center as needed. Contact: Reach your local ResMed representative or visit www.resmed.com/contact for questions.
Quantity in commerce: 168,069 devices globally
Distribution: Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. 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.
Product codes and lots: Catalog Number: Astral 100 UDI-DI code: 00619498003259 Serial Numbers: Astral Ventilators-Serial number < 22241890149 PCBA Spare Parts via physical PCBA or Ventilator UI - Characters 2 8 < 2707658 PCBA Spare Parts in Box - Box serial number < 22241978070 Catalog Number: Astral 150 UDI-DI code: 00619498270033 Serial Numbers: Astral Ventilator-Serial numbers < 22241440282 PCBA Spare Parts via physical PCBA or Ventilator UI - Characters 2 8 < 2707658 PCBA Spare Parts in Box - Box serial number < 22241978070

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2735-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2735-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-08-05	2026-07-28

Product code CBK

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)