Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that provides continuous or ...
FDA Device Recall #Z-2735-2026 - Class I, June 25, 2026
Recall Summary
| Recall Number | Z-2735-2026 |
| Classification | Class I - Serious risk |
| Date Initiated | June 25, 2026 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | ResMed Ltd. |
| Location | Bella Vista, N/A |
| Product Type | Devices |
| Quantity | 168,069 devices globally |
Product Description
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.
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.
Distribution Pattern
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 / Code Information
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
Other Recalls from ResMed Ltd.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0538-2024 | Class I | AirTouch F20 Full Face Mask and User Guide | Nov 20, 2023 |
| Z-0540-2024 | Class I | AirTouch N20 Nasal Mask and User Guide | Nov 20, 2023 |
| Z-0541-2024 | Class I | AirFit F30 Full Face Mask and User Guide | Nov 20, 2023 |
| Z-0536-2024 | Class I | AirFit N10 Nasal Masks and User Guide | Nov 20, 2023 |
| Z-0537-2024 | Class I | AirFit F20 Full Face Mask and User Guide | Nov 20, 2023 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic, removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency, Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.