FDA Medical Device Recalls (openFDA)
Caire, Inc.: CAIRE MODEL: FreeStyle Comfort Oxygen Concentrator - Product Usage: The FreeStyle Comfort Oxygen Concentrator is intended for the administration of supplemental oxygen. The device is not intended for life support nor does it provide any patient monitoring capabilities.
- Recall number
- Z-0805-2020
- Recalling firm
- Caire, Inc.
- Product
- CAIRE MODEL: FreeStyle Comfort Oxygen Concentrator - Product Usage: The FreeStyle Comfort Oxygen Concentrator is intended for the administration of supplemental oxygen. The device is not intended for life support nor does it provide any patient monitoring capabilities.
- Status
- Terminated
- Initiated
- 2019-11-21
- Posted
- not on file
- Terminated
- 2020-11-20
- Reason
- Four units of European version FreeStyle Comfort were distributed in the US, but were not cleared for use in the US..
- Root cause
- Packaging process control
- Action
- The firm initiated the recall by telephone and email on 11/19/2019, then followed with a letter on 12/04/2019. The firm requested the removal of all units and will exchange them for the US approved version.
- Quantity
- 4 units
- Distribution
- US Nationwide distribution in the states of MI, CA, CT.
- Lot, serial or model codes
- Serial Numbers: CBB5219310254, CBB5219310255, CBB5219310279, CBB5219310280
- 510(k) numbers
- not on file
- 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