ResMed Recalls
13 recalls on record · June 17, 2015 to August 5, 2026 · Medical Devices
Recalls by year
15
16
20
23
26
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
August 5, 2026Medical DevicesFDA
ResMed Ltd. recalls Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that provides continuous or intermittent ventilator
Hazard: 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.
December 27, 2023Medical DevicesFDA
ResMed Ltd. recalls AirFit F30i Full Face Mask and User Guide
Hazard: 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
December 27, 2023Medical DevicesFDA
ResMed Ltd. recalls AirFit F30 Full Face Mask and User Guide
Hazard: 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
December 27, 2023Medical DevicesFDA
ResMed Ltd. recalls AirTouch N20 Nasal Mask and User Guide
Hazard: 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
December 27, 2023Medical DevicesFDA
ResMed Ltd. recalls AirFit N20 Nasal Mask and User Guide
Hazard: 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
December 27, 2023Medical DevicesFDA
ResMed Ltd. recalls AirTouch F20 Full Face Mask and User Guide
Hazard: 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
December 27, 2023Medical DevicesFDA
ResMed Ltd. recalls AirFit F20 Full Face Mask and User Guide
Hazard: 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
December 27, 2023Medical DevicesFDA
ResMed Ltd. recalls AirFit N10 Nasal Masks and User Guide
Hazard: 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
November 1, 2023Medical DevicesFDA
ResMed Ltd. recalls Astral 100 and Astral 150 ventilators
Hazard: 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
February 12, 2020Medical DevicesFDA
ResMed Ltd. recalls ResMed Stellar, Non-invasive/invasive ventilators, Model: 100, 150
Hazard: 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.
August 24, 2016Medical DevicesFDA
Resmed Corporation recalls Quattro Air FFM MED AMER, Product Code: 62702, full face mask for use with active-exhaust-valve ventilators
Hazard: Masks in this lot, labelled and sold as 62702 vented Quattro Air FFM size Medium actually contain a non-vented (NV) Quattro Air FFM Large mask.
February 10, 2016Medical DevicesFDA
Resmed Corporation recalls Astral 100, 150 Model: 27001, 27003 In the US, Astral devices are primarily used as non-invasive homecare devices, for
Hazard: Resmed Corporation is recalling Astral 100, 150 External Battery because of a start-up issue.
June 17, 2015Medical DevicesFDA
ResMed Ltd. recalls Astral 100 ( Model No. 27001) & Astral 150 (Model No. 27003) ventilator.
Hazard: The Astral device allows clinicians to disable all alarms including those that detect circuit disconnection. Inappropriate disabling of alarms in ventilator dependent patients can lead to hazards of insufficient ventilation and insufficient expiratory pressure which can result in major severity harm.