ResMed Ltd.: 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.

Recall number

Z-2735-2026

Recalling firm

ResMed Ltd.

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.

Status

Open, Classified

Initiated

2026-06-25

Posted

2026-07-28

Terminated

not on file

Reason

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

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

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.

Lot, serial or model codes

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

510(k) numbers

["K152068","K172875"]

PMA numbers

not on file

Product code

CBK

Firm FEI

3004604967

Firm city

Bella Vista

Firm state

not on file

Firm country

Australia

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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