FDA Medical Device Recalls (openFDA)
Caire, Inc.: CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-101.
- Recall number
- Z-0479-2025
- Recalling firm
- Caire, Inc.
- Product
- CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-101.
- Status
- Completed
- Initiated
- 2024-10-04
- Posted
- 2024-11-15
- Terminated
- not on file
- Reason
- Potential failure of affected units to recharge the battery of the oxygen concentrators.
- Root cause
- Nonconforming Material/Component
- Action
- The recalling firm issued letters via email on and dated 10/4/2024 to their "sold-to" DME (durable medical equipment) distributors. The letter explained the reason for recall, identified the affected serial numbers and when they were shipped to the DME distributor, and requested the devices be returned to the recalling firm immediately. They are informed the devices will be replaced with new or repaired units. The DME distributor is to contact the CAIRE Customer Service via phone or email to arrange for return of the devices. A Response Form: Acknowledgement of Receipt was enclosed to indicate they have read and understand the recall instructions.
- Quantity
- 23 concentrators
- Distribution
- Worldwide distribution - US Nationwide, including PR and the countries of Israel and Peru.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K020324"]
- PMA numbers
- not on file
- Product code
- CAW
- Firm FEI
- 3004972304
- Firm city
- Ball Ground
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28