Astral 100 (
Medical device recall Z-1750-2015. Published in FDA’s Enforcement Report on Jun 17, 2015.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jun 17, 2015. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 1519 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“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.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Astral 100 ( Model No. 27001) & Astral 150 (Model No. 27003) ventilator.
1519 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial No. 22141256746 22141256747 22141256749 22141256750 22141256752 22141256753 22141256754 22141256755 22141256756 22141256757 22141256758 22141256759 22141256760 22141256761 22141256762 22141256763 22141256764 22141256765 22141256766…
Every code shown here, 1,991 characters
Serial No. 22141256746 22141256747 22141256749 22141256750 22141256752 22141256753 22141256754 22141256755 22141256756 22141256757 22141256758 22141256759 22141256760 22141256761 22141256762 22141256763 22141256764 22141256765 22141256766 22141256767 22141256768 22141256770 22141256771 22141256773 22141256774 22141256776 22141256777 22141256778 22141256780 22141256781 22141256782 22141256783 22141256784 22141256785 22141256786 22141256787 22141256788 22141256789 22141256790 22141256792 22141256793 22141256795 22141256796 22141256797 22141256798 22141256800 22141256802 22141256803 22141256804 22141256805 22141256808 22141256809 22141256810 22141256811 22141256812 22141256813 22141269796 22141269797 22141269798 22141269800 22141269801 22141269802 22141269803 22141269804 22141269805 22141269806 22141269807 22141269808 22141269809 22141269810 22141269811 22141269812 22141269813 22141269814 22141269815 22141269817 22141269818 22141269819 22141269820 22141269821 22141269822 22141269823 22141269824 22141269825 22141269826 22141269827 22141269828 22141269829 22141269830 22141269831 22141269832 22141269833 22141269834 22141269835 22141269836 22141269837 22141269838 22141269841 22141269842 22141269843 22141269844 22141269846 22141269847 22141269848 22141269849 22141269850 22141269851 22141269852 22141269853 22141269856 22141269858 22141269859 22141269860 22141269861 22141269862 22141269865 22141269866 22141269867 22141269868 22141269869 22141269870 22141269872 22141269873 22141269874 22141269875 22141269877 22141269878 22141269879 22141269881 22141269882 22141269883 22141269887 22141269888 22141269889 22141269890 22141269891 22141269893 22141269894 22141269895 22141269897 22141269898 22141269899 22141269900 22141269902 22141269904 22141269906 22141269908 22141269911 22141269915 22141297617 22141297619 22141297620 22141297621 22141297623 22141297629 22141297633 22141297635 22141297637 22141297638 22141297639 22141297641 22141297643 22141297646 22141297647 22141297650…
FDA’s list runs to 19,018 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide distribution. US nationwide, Uruguay and Canada.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on May 5, 2015.
- FDA classified it on Jun 10, 2015.
- FDA’s Enforcement Report published it on Jun 17, 2015.
- FDA terminated it on Apr 7, 2016.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- ResMed Ltd., of Bella Vista, NSW, Australia.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 19,018 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.