CAIRE FreeStyle Comfort portable oxygen concentrator battery recharge failure
Caire Inc. is recalling 26 CAIRE FreeStyle Comfort portable oxygen concentrators due to potential battery recharge failure. Affected units identified by serial number may not charge properly.
What this means for you
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: This is a Class II FDA recall of a critical medical device. The battery recharge failure creates a risk of harm to oxygen-dependent patients. As a risk-of-harm product without reported illness or injury, it meets the rubric criterion for severity score 3.
Plain-English summary
Caire Inc. is recalling 26 CAIRE FreeStyle Comfort portable oxygen concentrators, model AS200-2. The FDA has classified this as a Class II recall with recall number Z-0481-2025.
The defect involves a potential failure of the battery to recharge properly. The 26 affected units are identified by specific serial numbers and have been distributed worldwide, including throughout the United States (including Puerto Rico), Israel, and Peru.
Without proper battery recharge capability, the oxygen concentrators may not function reliably when powered by battery, affecting patients who depend on these devices for oxygen therapy.
The recalled product
- Product
- CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-2.
- Manufacturer
- Caire, Inc.
- Hazard
- battery-failure
- device-malfunction
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- No UDI-DI (for export only)
- Serial numbers: CBB5224350777
- CBB5224350774
- CBB5224350743
- CBB5224350723
- CBB5224350710
- CBB5224350653
- CBB5224350648
- CBB5224350636
- CBB5224350606
- CBB5224350583
- CBB5224350580
- CBB5224350575
- CBB5224350573
- CBB5224350567
- CBB5224350512
- CBB5224350510
- CBB5224350509
- CBB5224350508
- CBB5224350498
Distribution
Distributed nationwide across the United States.
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