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U.S. Department of Health and Human Services

Class 2 Device Recall FreeStyle Comfort Oxygen Concentrator

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 Class 2 Device Recall FreeStyle Comfort Oxygen Concentratorsee related information
Date Initiated by FirmOctober 04, 2024
Date PostedNovember 15, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0481-2025
Recall Event ID 95576
Product Classification Generator, oxygen, portable - Product Code CAW
ProductCAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-2.
Code Information No UDI-DI (for export only); Serial numbers: CBB5224350777, CBB5224350774, CBB5224350743, CBB5224350723, CBB5224350710, CBB5224350653, CBB5224350648, CBB5224350636, CBB5224350606, CBB5224350583, CBB5224350580, CBB5224350575, CBB5224350573, CBB5224350567, CBB5224350512, CBB5224350510, CBB5224350509, CBB5224350508, CBB5224350498, CBB5224350492, CBB5224350490, CBB5224350475, CBB5224350474, CBB5224350468, CBB5224350460, and CBB5224350459.
Recalling Firm/
Manufacturer		 Caire, Inc.
2200 Airport Industrial Dr Ste 500
Ball Ground GA 30107-4686
For Additional Information ContactSheril Ray
770-7217719
Manufacturer Reason
for Recall		Potential failure of affected units to recharge the battery of the oxygen concentrators.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionThe recalling firm issued letters via email on and dated 10/4/2024 to their "sold-to" DME (durable medical equipment) distributors. The letter explained the reason for recall, identified the affected serial numbers and when they were shipped to the DME distributor, and requested the devices be returned to the recalling firm immediately. They are informed the devices will be replaced with new or repaired units. The DME distributor is to contact the CAIRE Customer Service via phone or email to arrange for return of the devices. A Response Form: Acknowledgement of Receipt was enclosed to indicate they have read and understand the recall instructions.
Quantity in Commerce26 concentrators
DistributionWorldwide distribution - US Nationwide, including PR and the countries of Israel and Peru.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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