Bella Vista, N/A, Australia
ResMed Ltd. recalls
4 recalls recorded since 2018, most recently on 25 June 2026. 3 are listed as ongoing. Status and classification are as published by the FDA.
Recalls4
Ongoing (FDA)3
Terminated or completed1
Class I (FDA)4
Ongoing Class I Medical devices
- Recall started
- 25 June 2026
- 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.
- 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, Ar
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2735-2026
- 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.
Ongoing Class I Medical devices
- Recall started
- 20 November 2023
- Reason
- Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical implants that interact with magnets, and metallic implants/objects containing ferromagnetic material so contraindications and warnings about safe distance to medical devices/implants are being updated for patients using masks or anyone in close physical contact
- Distribution
- US nationwide distribution including Puerto Rico, Guam, and Virgin Islands. OUS (foreign) countries of: AE, AR, AT, AU, BB, BD, BE, BG, BH, BM, BR, CA, CH, CL, CN, CO, CW, CY, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FO, FR, GB, GF, GG, GL, GP, GR, GT, GY, HK, HN, HR, HU, ID, IE, IL, IM, IN, IR, IS,
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0538-2024, Z-0540-2024, Z-0541-2024, Z-0536-2024, Z-0537-2024, Z-0542-2024, Z-0539-2024
- AirTouch F20 Full Face Mask and User Guide
- AirTouch N20 Nasal Mask and User Guide
- AirFit F30 Full Face Mask and User Guide
- AirFit N10 Nasal Masks and User Guide
- AirFit F20 Full Face Mask and User Guide
- AirFit F30i Full Face Mask and User Guide
- AirFit N20 Nasal Mask and User Guide
Ongoing Class I Medical devices
- Recall started
- 13 September 2023
- Reason
- If ventilator is on internal battery, not intended to serve as a primary power source, low/critically low battery alarms will sound, but a fault leads to sudden power loss. If power fails, then ventilation stops and a Total Power Failure (TPF) alarm should sound, but it's powered by a supercapacitor, which degrades over time, which may cause TPF alarm to sound for less than 2 minutes or not at all
- Distribution
- Worldwide - US Nationwide distribution including in the states of CA, NJ, VA, IN, MI, WV, NY, WI, ND, IL, NC, FL, CO, TX, AL, LA, MD, OR, AZ, MN, WA, PA, SC, MA, ID, GA, SD, TN, NH, OH, MS, CT, IA, KY, UT, NE, MO, NV, AR, WY, RI, KS, VT, ME, OK, PR, MO, DC and the countries of Taiwan, Israel, Spain,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0111-2024
- Astral 100 and Astral 150 ventilators
Completed Class I Medical devices
- Recall started
- 12 December 2019
- Reason
- Combination of software and a component failure may cause audible alarms not to operate properly, the alarm buzzer not work, for ventilators that have a failed electronic component and, that are stored without AC power connected for more than 36 hours leading to full depletion of the battery and, that powers on automatically when connected to AC power without pressing the power switch.
- Distribution
- U.S.: PA, MA, VA, TN, CT, IL, GA, FL, MT
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0915-2020
- ResMed Stellar, Non-invasive/invasive ventilators, Model: 100, 150
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.