Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
CAIRE MODEL: FreeStyle Comfort Oxygen Concentrator - Product Usage: The Recalled by Caire, Inc. Due to Four units of European version FreeStyle Comfort were...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Caire, Inc. directly.
Affected Products
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.
Quantity: 4 units
Why Was This Recalled?
Four units of European version FreeStyle Comfort were distributed in the US, but were not cleared for use in the US..
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Caire, Inc.
Caire, Inc. has 11 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report