Astral 100, 150
Medical device recall Z-0746-2016. Published in FDA’s Enforcement Report on Feb 10, 2016.
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 Feb 10, 2016. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- 31 states named in where it went
- 14,736 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?
Resmed Corporation is recalling Astral 100, 150 External Battery because of a start-up issue.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Astral 100, 150 Model: 27001, 27003 In the US, Astral devices are primarily used as non-invasive homecare devices, for example, the largest population of patients on the Astral device is COPD patients primarily using the device at night with some daytime use for recovery breathing. While it is possible that there may be scenarios where critically dependent patients may encounter this scenario, the likelihood of this leading to harm is negligible because critically dependent patients will have a form of backup ventilation as standard of care.
14,736, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: 22141311907 22151237236 22141311910 22151237228 22151572231 22151666684 22151237233 22151135073 22141458006 22151572230 22151135061 22151397090 22151008941 22141311872 22151614456 22151135058 22141269867 22151555593…
Every code shown here, 1,996 characters
Serial Numbers: 22141311907 22151237236 22141311910 22151237228 22151572231 22151666684 22151237233 22151135073 22141458006 22151572230 22151135061 22151397090 22151008941 22141311872 22151614456 22151135058 22141269867 22151555593 22151483516 22151483534 22151325490 22151163315 22141308812 22151555584 22151311349 22141311870 22151602423 22151325513 22151555618 22151165427 22151165476 22151468419 22151397046 22151073624 22151165376 22151602615 22151445731 22151326787 22151483592 22151602601 22151165492 22151555637 22151311317 22151608382 22151608488 22151310708 22151326727 22151165536 22151468487 22151165539 22151503647 22151310704 22151602504 22141311844 22151572224 22151503641 22151399554 22141668174 22151468486 22151397041 22151602409 22151311327 22151483580 22151483551 22151602621 22151614517 22151602637 22151445633 22151602631 22151009061 22151397094 22151397076 22151445751 22151483560 22151555656 22151483543 22151555621 22151325478 22151614509 22151445655 22151161883 22141668179 22151310724 22151445705 22151468414 22151326801 22151135048 22151349223 22151298935 22151165471 22151445645 22151326730 22151515901 22151483517 22151602491 22151514288 22151483533 22151163339 22151224469 22151602641 22151326810 22151555589 22151468523 22151445643 22151326723 22151602608 22151445756 22151399564 22151399540 22151349248 22151326815 22141322503 22151310718 22151608454 22151326837 22151468411 22151483527 22151397132 22151325496 22151326710 22141308814 22151602448 22151022615 22151009030 22151515943 22151031747 22151073632 22151602650 22151311328 22151514256 22151608420 22151163319 22141381474 22151022621 22141620659 22141297647 22151468485 22151483825 22151468517 22151483490 22151165378 22151445755 22151399532 22151555653 22151009060 22151515947 22151397033 22141308871 22151445725 22151249725 22151483572 22151483601 22151399539 22151468483 22151468475 22141322553 22151608443 22151602425 22151483836 22151310729 22151325520 22151602597 22151608380 22141647461 22151503634…
FDA’s list runs to 34,264 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 including VA, FL, MO, CA, LA, TX, NJ, NH, NC, WV, MI, ID, OK, MI, MN, UT, CT, IL, AZ, UT, KY, MT, PA, RI, TN, DE, NE, LA, NY, SC, WY, IN, VA, GA, CO and Internationally to CA, CO, and AR.
The states and territories these words name
31 states and territories.
Every one of them
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Idaho
- Illinois
- Indiana
- Kentucky
- Louisiana
- Michigan
- Minnesota
- Missouri
- Montana
- North Carolina
- Nebraska
- New Hampshire
- New Jersey
- New York
- Oklahoma
- Pennsylvania
- Rhode Island
- South Carolina
- Tennessee
- Texas
- Utah
- Virginia
- West Virginia
- Wyoming
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
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 Jan 13, 2016.
- FDA classified it on Feb 3, 2016.
- FDA’s Enforcement Report published it on Feb 10, 2016.
- FDA terminated it on Apr 22, 2016.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Resmed Corporation, of San Diego, CA.
- 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 34,264 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
-
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.