FDA Medical devices recall ·
React Health PHOENIX 5L Oxygen Concentrator recall
- Recall number
- Z-1815-2026
- Date
- (initiated February 4, 2026)
- Company / brand
- 3B Medical, Inc.
5475 Rings Rd Ste 550, Dublin, OH, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 2 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
React Health PHOENIX 5L Oxygen Concentrator
Why was it recalled?
Devices which did not meet internal quality specifications were inadvertently distributed.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI 06934726614439-250623-MZJ5S713971, Serial Number MZJ5S713971; UDI 06934726614439-250623-MZJ5S714009, Serial Number MZJ5S714009
Distribution
US Nationwide distribution in the state of NY.
States: New York
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1815-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.