CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-103.
FDA Recall #Z-0480-2025 — Class II — October 4, 2024
Product Description
CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-103.
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
6 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 CBB5224350751, CBB5224350720, CBB5224350604, CBB5224350601, CBB5224350598, and CBB5224350582.
Status
Completed
Voluntary / Mandated
Voluntary: Firm initiated