FDAMarch 25, 2022device
CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE, model #AS200-3
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The device was not cleared for U.S. distribution.
What to do
FDA enforcement status: Terminated
Brands named
caire
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDACAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-2.2024-10-04
- FDACAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-101.2024-10-04
- FDACAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-1.2024-10-04
- FDACAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-103.2024-10-04
- FDACAIRE Liberator 45, MODEL 13261699, Liquid Oxygen System Unit2022-10-10
- FDACAIRE Liberator 45, MODEL 13262253, Liquid Oxygen System Unit2022-10-10
- FDACAIRE Liberator 30, MODEL 13337403, Liquid Oxygen System Unit2022-10-10
- FDACAIRE Liberator 20, MODEL 13256195, Liquid Oxygen System Unit2022-10-10
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