Caire, Inc. 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Caire, Inc.
Lot Codes / Batch Numbers
Serial Numbers: CBB5219310254, CBB5219310255, CBB5219310279, CBB5219310280
Products Sold
Serial Numbers: CBB5219310254, CBB5219310255, CBB5219310279, CBB5219310280
Caire, Inc. is recalling CAIRE MODEL: FreeStyle Comfort Oxygen Concentrator - Product Usage: The FreeStyle Comfort Oxygen Con due to Four units of European version FreeStyle Comfort were distributed in the US, but were not cleared for use in the US... Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Four units of European version FreeStyle Comfort were distributed in the US, but were not cleared for use in the US..
Recommended Action
Per FDA guidance
The firm initiated the recall by telephone and email on 11/19/2019, then followed with a letter on 12/04/2019. The firm requested the removal of all units and will exchange them for the US approved version.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026