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Caire, Inc. FDA Recalls

9 recalls on file across devices, 4 of them Class I and 0 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-1.Class IIOct 4, 2024Potential failure of affected units to recharge the battery	Potential failure of affected units to recharge the battery of the oxygen concentrators.	Class IIDevices	Oct 4, 2024
CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-101.Class IIOct 4, 2024Potential failure of affected units to recharge the battery	Potential failure of affected units to recharge the battery of the oxygen concentrators.	Class IIDevices	Oct 4, 2024
CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-103.Class IIOct 4, 2024Potential failure of affected units to recharge the battery	Potential failure of affected units to recharge the battery of the oxygen concentrators.	Class IIDevices	Oct 4, 2024
CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-2.Class IIOct 4, 2024Potential failure of affected units to recharge the battery	Potential failure of affected units to recharge the battery of the oxygen concentrators.	Class IIDevices	Oct 4, 2024
CAIRE Liberator 20, MODEL 13256195, Liquid Oxygen System UnitClass IOct 10, 2022An audit discovered some inconsistencies in weld penetration	An audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the inner bottle	Class IDevices	Oct 10, 2022
CAIRE Liberator 45, MODEL 13261699, Liquid Oxygen System UnitClass IOct 10, 2022An audit discovered some inconsistencies in weld penetration	An audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the inner bottle	Class IDevices	Oct 10, 2022
CAIRE Liberator 45, MODEL 13262253, Liquid Oxygen System UnitClass IOct 10, 2022An audit discovered some inconsistencies in weld penetration	An audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the inner bottle	Class IDevices	Oct 10, 2022
CAIRE Liberator 30, MODEL 13337403, Liquid Oxygen System UnitClass IOct 10, 2022An audit discovered some inconsistencies in weld penetration	An audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the inner bottle	Class IDevices	Oct 10, 2022
CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE, model #AS200-3Class IIMar 25, 2022The device was not cleared for U.S. distribution.	The device was not cleared for U.S. distribution.	Class IIDevices	Mar 25, 2022

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