FDAFDA · Food and drugs·Recall number Z-0479-2025
CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-101.
Published November 27, 2024 · Recall initiated: October 4, 2024
Status when published: Completed — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Potential failure of affected units to recharge the battery of the oxygen concentrators.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Caire, Inc.
- Distributor
- Worldwide distribution - US Nationwide, including PR and the countries of Israel and Peru.
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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