Caire, Inc.: Device Recall
Recall #Z-0479-2025 · 10/04/2024
Class II: Risk
Recall Details
- Recall Number
- Z-0479-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Caire, Inc.
- Status
- Completed
- Date Initiated
- 10/04/2024
- Location
- Ball Ground, GA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 23 concentrators
Reason for Recall
Potential failure of affected units to recharge the battery of the oxygen concentrators.
Product Description
CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-101.
Distribution Pattern
Worldwide distribution - US Nationwide, including PR and the countries of Israel and Peru.
Other Recalls by Caire, Inc.
- Class II: Risk 10/04/2024
- Class II: Risk 10/04/2024
- Class II: Risk 10/04/2024
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.