FDA Devices recall · Reported November 1, 2023
Astral 100 and Astral 150 ventilators
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 pow…
ResMed Ltd. recalled Astral 100 and Astral 150 ventilators - a critical-severity action.
Astral 100 and Astral 150 ventilators was recalled by ResMed Ltd. in November 1, 2023. Reason: If ventilator is on internal battery, not intended to serve as a primary power source, low/critically low bat…. Check the official notice for the remedy. Verify recall #Z-0111-2024 with the FDA Devices before acting.
The recall
ResMed Ltd. issued this critical-severity FDA Devices recall-If ventilator is on internal battery, not intended to serve as a primary power source, low/critically low bat….
- Critical
- severity level
- Class I
- classification
- November 1, 2023
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0111-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
Astral 100 and Astral 150 ventilators
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
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Ongoing |
| Recall number | Z-0111-2024 |
| Date reported | November 1, 2023 |
| Date initiated | September 13, 2023 |
| Recalling firm | ResMed Ltd. |
| Firm location | Bella Vista, N/A |
| Affected scope | 55,279 (US 16,634; OUS 38,645) |
| Distribution | 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, M… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0111-2024) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Critical), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026