FDA Medical Device Recalls (openFDA)
Caire, Inc.: CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE, model #AS200-3
- Recall number
- Z-1117-2022
- Recalling firm
- Caire, Inc.
- Product
- CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE, model #AS200-3
- Status
- Terminated
- Initiated
- 2022-03-25
- Posted
- not on file
- Terminated
- 2023-10-05
- Reason
- The device was not cleared for U.S. distribution.
- Root cause
- No Marketing Application
- Action
- The recalling firm initially contacted the customer via voicemail and email on 3/25/2022. The email informed the consignee that the two affected units that were shipped to them could not be sold in the U.S. or its territories due to FDA approval. The email requested the consignee confirm their address so that call tags could be sent to them for return of the affected units. The consignee was informed the units will be replaced with the new AS200-1 units as soon as the recalled units are returned. The model and serial numbers were provided of the affected units. The voicemail message summarized the information that was in the email.
- Quantity
- 2 oxygen concentrators
- Distribution
- Distribution was made to Puerto Rico. There was no foreign/government/military distribution.
- Lot, serial or model codes
- Serial numbers CBB5221200337 and CBB5221200287.
- 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