Resmed Ltd
FDA adverse event reports naming Resmed Ltd as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: RESMED LTD.
- Total reports
- 14,714
- Deaths
- 126
- Injuries
- 135
- Malfunctions
- 14,444
Reports per year
Source: FDA adverse event reports by year received, 2010–2024. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.
Top device categories
- Ventilator, Continuous, Facility UseCBK10,560
- Continuous, Ventilator, Home UseNOU3,745
- Ventilator, Non-Continuous (Respirator)BZD269
- Cannula, Nasal, OxygenCAT51
- Sv70 VentilatorMNT49
- Ventilator, Continuous, Non-Life-SupportingMNS14
- Generator, Oxygen, PortableCAW7
- Product code ------2
- Mask, OxygenBYG2
- Hearing Aid, Bone Conduction, ImplantedMAH2
Recent recalls
- 2026-07-28Open, ClassifiedComponent design/selection
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.
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.
- 2023-12-21Open, ClassifiedDevice Design
AirFit N10 Nasal Masks and User Guide
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
- 2023-12-21Open, ClassifiedDevice Design
AirFit F20 Full Face Mask and User Guide
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
- 2023-12-21Open, ClassifiedDevice Design
AirTouch F20 Full Face Mask and User Guide
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
- 2023-12-21Open, ClassifiedDevice Design
AirFit N20 Nasal Mask and User Guide
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
- 2023-12-21Open, ClassifiedDevice Design
AirTouch N20 Nasal Mask and User Guide
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
- 2023-12-21Open, ClassifiedDevice Design
AirFit F30 Full Face Mask and User Guide
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
- 2023-12-21Open, ClassifiedDevice Design
AirFit F30i Full Face Mask and User Guide
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
- 2023-10-23Open, ClassifiedDevice Design
Astral 100 and Astral 150 ventilators
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
- 2015-06-10TerminatedUse error
Astral 100 ( Model No. 27001) & Astral 150 (Model No. 27003) ventilator.
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.
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