Caire, Inc. recalls CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-103.
- Recall date
- October 4, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0480-2025
- FDA classification
- Class II
- Brand / firm
- Caire, Inc.
- Sold / distributed
- Worldwide distribution - US Nationwide, including PR and the countries of Israel and Peru.
Why it was recalled
Potential failure of affected units to recharge the battery of the oxygen concentrators.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-103.
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