React Health PHOENIX 5L Oxygen Concentrator recallZ-1815-2026 · 3B Medical, Inc. · initiated Feb 4, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from 3B Medical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Devices which did not meet internal quality specifications were inadvertently distributed.
FDA root cause category: Storage
What the company is doing
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).
Recall details
- Recall number
- Z-1815-2026
- Status
- Open, Classified
- Initiated by the company
- Feb 4, 2026
- Posted by the FDA
- Apr 15, 2026
- Recalling firm
- 3B Medical, Inc.
- Quantity
- 2 units
- Product code
- CAW
- FDA submissions
- K213210
- Distribution
- US Nationwide distribution in the state of NY.
Product description
React Health PHOENIX 5L Oxygen Concentrator
Code information (models, lots, serial numbers)
UDI 06934726614439-250623-MZJ5S713971, Serial Number MZJ5S713971; UDI 06934726614439-250623-MZJ5S714009, Serial Number MZJ5S714009
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- React Health Phoenix 5 SOC5100Longfian Scitech Co., Ltd. · Generator, Oxygen, Portable1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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