Resmed Recalls Astral 100 and 150 External Batteries Due to Start-Up Issue
Resmed Corporation is recalling Astral 100 and 150 external batteries because of a start-up issue. The recall affects 14,736 units distributed in the US and internationally.
The agency’s classification
FDA (Devices): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, a Class II recall without reported hospitalizations or injuries falls under 'High' (Score 3), representing a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Resmed Corporation is recalling Astral 100 and 150 external batteries (models 27001 and 27003) due to a start-up issue. The recall covers 14,736 units that were distributed worldwide, including in the United States and internationally to Canada, Colombia, and Argentina.
In the US, these Astral devices are primarily used as non-invasive homecare devices, with the largest patient population being individuals with COPD who use the device at night and during the day for recovery breathing. While critically dependent patients may encounter this scenario, the likelihood of harm is considered negligible because such patients typically have backup ventilation as part of standard care.
Consumers should check their device serial numbers against the list provided in the official recall notice to determine if their unit is affected. No specific consumer action instructions (such as stopping use or contacting support) are detailed in the provided source text.
The recalled product
- Product
- 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…
- Manufacturer
- Resmed Corporation
- Hazard
- Affected units
- 14,736
Distribution
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