Resmed recalls
Resmed appears in 13 official U.S. recall notices indexed by RecallRadar, most recently on 2026-08-05.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 13 |
|---|---|
| Published | 2015-06-17 to 2026-08-05 |
| By agency | FDA Device (13) |
| By classification | Class I (10), Class II (3) |
| By status | ongoing (9), terminated (3), completed (1) |
| Distribution named in notices | AR, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, KY, LA, MA, MI, MN, MO, MT, NC, NE, NH, NJ, NY, OK, PA, RI, SC, TN, TX, US, UT, VA, WV, WY |
Recalls
- Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that provides continuous or intermittent ventilatory support for patients…
FDA Device · Class I · 2026-08-05 · Resmed
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. - AirFit N10 Nasal Masks and User Guide
FDA Device · Class I · 2023-12-27 · Resmed
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 fe… - AirFit F30 Full Face Mask and User Guide
FDA Device · Class I · 2023-12-27 · Resmed
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 fe… - AirFit N20 Nasal Mask and User Guide
FDA Device · Class I · 2023-12-27 · Resmed
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 fe… - AirFit F30i Full Face Mask and User Guide
FDA Device · Class I · 2023-12-27 · Resmed
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 fe… - AirTouch N20 Nasal Mask and User Guide
FDA Device · Class I · 2023-12-27 · Resmed
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 fe… - AirFit F20 Full Face Mask and User Guide
FDA Device · Class I · 2023-12-27 · Resmed
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 fe… - AirTouch F20 Full Face Mask and User Guide
FDA Device · Class I · 2023-12-27 · Resmed
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 fe… - Astral 100 and Astral 150 ventilators
FDA Device · Class I · 2023-11-01 · Resmed
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 T… - ResMed Stellar, Non-invasive/invasive ventilators, Model: 100, 150
FDA Device · Class I · 2020-02-12 · Resmed
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… - Quattro Air FFM MED AMER, Product Code: 62702, full face mask for use with active-exhaust-valve ventilators
FDA Device · Class II · 2016-08-24 · Resmed
Reason: 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. - Astral 100, 150 Model: 27001, 27003 In the US, Astral devices are primarily used as non-invasive homecare devices, for example, the largest…
FDA Device · Class II · 2016-02-10 · Resmed
Reason: Resmed Corporation is recalling Astral 100, 150 External Battery because of a start-up issue. - Astral 100 ( Model No. 27001) & Astral 150 (Model No. 27003) ventilator
FDA Device · Class II · 2015-06-17 · Resmed
Reason: 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 ventila…