Food, drugs, devices › ResMed Ltd.
Device recall: Astral 100 ( Model No. 27001) & Astral 150 (Model No. 27003) ventilator.
ResMed Ltd. (Bella Vista, NSW, N/A) initiated this device recall on 5 May 2015; FDA lists 1 product record under event 71100, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,153 device enforcement events initiated in 2015 carry the same class.
Status: Terminated, terminated 7 Apr 2016. Initiation: voluntary: firm initiated. ResMed Ltd. has 5 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
ResMed Ltd., Bella Vista, NSW, N/A, Australia.
Reason for recall
"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."
Distribution
"Worldwide distribution. US nationwide, Uruguay and Canada."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1750-2015 | Astral 100 ( Model No. 27001) & Astral 150 (Model No. 27003) ventilator. | 1519 units | Class II | Terminated | 17 Jun 2015 |
Context
Other enforcement events for ResMed Ltd.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 25 Jun 2026 | Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that provides continuous or intermittent ventilatory s | Device | Class I | 1 |
| 20 Nov 2023 | AirFit N10 Nasal Masks and User Guide | Device | Class I | 7 |
| 13 Sep 2023 | Astral 100 and Astral 150 ventilators | Device | Class I | 1 |
| 12 Dec 2019 | ResMed Stellar, Non-invasive/invasive ventilators, Model: 100, 150 | Device | Class I | 1 |
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide distribution. US nationwide, Uruguay and Canada."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 7 Apr 2016. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.