CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-2.
FDA Recall #Z-0481-2025 — Class II — October 4, 2024
Product Description
CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-2.
Reason for Recall
Potential failure of affected units to recharge the battery of the oxygen concentrators.
Recalling Firm
Caire, Inc. — Ball Ground, GA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
26 concentrators
Distribution
Worldwide distribution - US Nationwide, including PR and the countries of Israel and Peru.
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.
Status
Completed
Voluntary / Mandated
Voluntary: Firm initiated