FDA Medical Device Recalls (openFDA)
3B Medical, Inc.: React Health PHOENIX 5L Oxygen Concentrator
- Recall number
- Z-1815-2026
- Recalling firm
- 3B Medical, Inc.
- Product
- React Health PHOENIX 5L Oxygen Concentrator
- Status
- Open, Classified
- Initiated
- 2026-02-04
- Posted
- 2026-04-15
- Terminated
- not on file
- Reason
- Devices which did not meet internal quality specifications were inadvertently distributed.
- Root cause
- Storage
- Action
- React Health notified its sole consignee on 2/4/2026 via email. They followed with a MEDICAL DEVICE RECALL NOTIFICATION also sent via email on 3/5/2026. The notice explained the issue, potential risk, and requested the consignee contact React Health Customer Support at 863-226-6285 to discuss shipping arrangements, if necessary. For any questions, please contact React Health directly at 863-226-6285 , Monday through Friday between 8:00 a.m. - 5:00 p.m. Eastern Time (ET).
- Quantity
- 2 units
- Distribution
- US Nationwide distribution in the state of NY.
- Lot, serial or model codes
- UDI 06934726614439-250623-MZJ5S713971, Serial Number MZJ5S713971; UDI 06934726614439-250623-MZJ5S714009, Serial Number MZJ5S714009
- 510(k) numbers
- ["K213210"]
- PMA numbers
- not on file
- Product code
- CAW
- Firm FEI
- 3009096682
- Firm city
- Dublin
- Firm state
- OH
- 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