CLASS I ONGOING Device recall · Reported 1 Nov 2023 · FDA Enforcement Report

Astral 100 and Astral 150 ventilators recalled by ResMed

ResMed is recalling Astral 100 and Astral 150 ventilators, distributed nationwide in the US. The recall was initiated on 13 Sep 2023 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesAll devices manufactured between 2013 and 2019. Device label lists the serial number, which includes the year of manufacture. For example, if the serial number is 22151234567, the 3rd and 4th digit are 15, meaning the device was manufactured in 2015. Astral 100, UDI: 00619498003259 Astral 150, UDI: 00619498003266

Quantity recalled55,279 (US 16,634; OUS 38,645)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0111-2024
FDA event ID: 93122
Recalling firm: ResMed, Bella Vista, N/A
Classification: Class I
Status: Ongoing
Recall initiated: 13 Sep 2023
FDA classified: 23 Oct 2023
Reported: 1 Nov 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: CPAP & Ventilators

Timeline

13 Sep 2023	Recall initiated by company
23 Oct 2023	Classified by FDA	+40 days
1 Nov 2023	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Astral 100 and Astral 150 ventilators

Where it was distributed

Worldwide - US Nationwide distribution including in the states of CA, NJ, VA, IN, MI, WV, NY, WI, ND, IL, NC, FL, CO, TX, AL, LA, MD, OR, AZ, MN, WA, PA, SC, MA, ID, GA, SD, TN, NH, OH, MS, CT, IA, KY, UT, NE, MO, NV, AR, WY, RI, KS, VT, ME, OK, PR, MO, DC and the countries of Taiwan, Israel, Spain, Slovenia, Belgium, Italy, Australia, Guatemala, Argentina, Uruguay, Chile, France, Martinique, Germany, French Polynesia, Korea, Egypt, Colombia, United Kingdom, Jersey, Ecuador, Reunion, Greece, Brazil, Cyprus, Saudi Arabia, Czech Republic, Thailand, New Caledonia, Mauritius, Canada, Vietnam, Indonesia, Pakistan, Japan, Guadeloupe, South Africa, Iran, Hungary, Tunisia, Nepal, Iceland, New Zealand, Austria, Portugal, Malaysia, Norway, Netherlands, Sweden, Lebanon, Finland, Singapore, United Arab Emirates, Peru, Oman, Philippines, Bahrain, French Guiana, Mexico, Sri Lanka, India, Kuwait, Bangladesh, Kenya, Myanmar, Turkey, Bulgaria, Croatia, Hong Kong, Saint Martin, Qatar, Jordan, Romania, Maldives, Denmark, Poland.

Nationwide Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Florida Georgia Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Maine Michigan

Questions about this recall

Why was it recalled?

Which lots are affected?

All devices manufactured between 2013 and 2019. Device label lists the serial number, which includes the year of manufacture. For example, if the serial number is 22151234567, the 3rd and 4th digit are 15, meaning the device was manufactured in 2015. Astral 100, UDI: 00619498003259 Astral 150, UDI: 00619498003266

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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