DeviceSignal · Recall classified
ResMed Ltd.
FDA classified a device recall on 2026-07-28 · Class I · Z-2735-2026
EventRecall classified
Effective2026-07-28
ClassificationClass I
On 2026-07-28 the FDA classified a device recall from ResMed Ltd. as Class I. Product: Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that provides…. Recall Z-2735-2026. The firm initiated it on 2026-06-25. This reports the classification FDA published on that date.
Reported facts
- Recall number
- Z-2735-2026
- Classification
- Class I
- Classified on
- 2026-07-28
- Initiated on
- 2026-06-25
- Firm
- ResMed Ltd.
- Reason
- Due to a Supercapacitor electrolyte leakage on Printed Circuit Board Assembly (PCBA) may damage the charger chip, causing fail-safe state and interruption of ventilation therapy.
- Product
- Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that provides continuous or intermittent ventilatory support for patients weighing more than 11lb (5kg) who require mechanical ventilation.
Every field above is as fda_device_enforcement published it. Nothing on this page is our interpretation.
Provenance
- Source
- fda_device_enforcement
- Source record
Z-2735-2026- Snapshot hash
ab5ada73bf212eb52a548aab0968a0fcee42807c61b0350e60e24bb6e2beed72- Source URL
- https://download.open.fda.gov/device/enforcement/device-enforcement-0001-of-0001.json.zip
- Observed
- 2026-09-08T16:22:09.483Z
- Transform
fda_device_enforcement_to_recall v1- Event rule
fda_device_recall_classified v1- Event key
62176975636704bd20d302f92070dc51bb77be9b29cd443b7dda9580bbba3fbd- Signal type
device_recall.classified
Source terms that apply
- This is not a public alerting service and must not be used to notify patients or the public
- We do not report whether a recall is still open; FDA does not maintain that after classification
- Nothing here is a medical or clinical decision aid
- Not affiliated with, endorsed by, or certified by the FDA
Data provided by the U.S. Food and Drug Administration (https://open.fda.gov)