FDA Medical devices recall ·
CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-2 recall
- Recall number
- Z-0481-2025
- Date
- (initiated October 4, 2024)
- Company / brand
- Caire, Inc.
2200 Airport Industrial Dr Ste 500, Ball Ground, GA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Completed
- Units affected
- 26 concentrators
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-2.
Why was it recalled?
Potential failure of affected units to recharge the battery of the oxygen concentrators.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
No UDI-DI (for export only); Serial numbers: CBB5224350777, CBB5224350774, CBB5224350743, CBB5224350723, CBB5224350710, CBB5224350653, CBB5224350648, CBB5224350636, CBB5224350606, CBB5224350583, CBB5224350580, CBB5224350575, CBB5224350573, CBB5224350567, CBB5224350512, CBB5224350510, CBB5224350509, CBB5224350508, CBB5224350498, CBB5224350492, CBB5224350490, CBB5224350475, CBB5224350474, CBB5224350468, CBB5224350460, and CBB5224350459.
Distribution
Worldwide distribution - US Nationwide, including PR and the countries of Israel and Peru.
States: Puerto Rico
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0481-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.