CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-101.
FDA Recall #Z-0479-2025 — Class II — October 4, 2024
Product Description
CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-101.
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
23 concentrators
Distribution
Worldwide distribution - US Nationwide, including PR and the countries of Israel and Peru.
Code Information
UDI-DI: M766AS2001010; Serial numbers: CBB5224380888, CBB5224380868, CBB5224380846, CBB5224380842, CBB5224380298, CBB5224380295, CBB5224380282, CBB5224380251, CBB5224380011, CBB5224380010, CBB5224370651, CBB5224370598, CBB5224370445, CBB5224370431, CBB5224370420, CBB5224370230, CBB5224370227, CBB5224370191, CBB5224370185, CBB5224370168, CBB5224370165, CBB5224370009, and CBB5224350790.
Status
Completed
Voluntary / Mandated
Voluntary: Firm initiated