Caire FreeStyle Comfort Oxygen Concentrators Recalled for Lack of US Clearance
Caire, Inc. is recalling four European version FreeStyle Comfort Oxygen Concentrators because they were not cleared for use in the US.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is primarily regulatory (lack of US clearance) rather than a reported acute safety failure, fitting the Moderate category for low-risk or precautionary issues without reported harm.
Plain-English summary
Caire, Inc. is recalling four units of the FreeStyle Comfort Oxygen Concentrator. The specific units involved are European versions that were distributed in the United States but were not cleared for use in the US market.
The recall covers four specific units with serial numbers CBB5219310254, CBB5219310255, CBB5219310279, and CBB5219310280. These devices were distributed nationwide in the states of Michigan, California, and Connecticut. The FreeStyle Comfort Oxygen Concentrator is intended for the administration of supplemental oxygen and is not intended for life support or patient monitoring.
Consumers who possess these specific serial numbers should stop using the devices and contact Caire, Inc. for further instructions. The recall is classified as Class II by the FDA.
The recalled product
- Product
- CAIRE MODEL: FreeStyle Comfort Oxygen Concentrator - Product Usage: The FreeStyle Comfort Oxygen Concentrator is intended for the administration of supplemental oxygen. The device is not intended for life support nor does it provide any patient monitoring capabilities.
- Manufacturer
- Caire, Inc.
- Affected units
- 4
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 (4)
- Serial Numbers: CBB5219310254
- CBB5219310255
- CBB5219310279
- CBB5219310280
Distribution
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