Z-1815-2026 Class II Ongoing
FDA device recall Z-1815-2026 was initiated by 3B Medical, Inc. on February 4, 2026 and is designated Class II. Reason for recall: Devices which did not meet internal quality specifications were inadvertently distributed. The recall status is ongoing. Affected quantity: 2 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 22, 2026
- Initiation Date
- February 4, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 units
Product Description
React Health PHOENIX 5L Oxygen Concentrator
Reason for Recall
Devices which did not meet internal quality specifications were inadvertently distributed.
Distribution Pattern
US Nationwide distribution in the state of NY.
Code Information
UDI 06934726614439-250623-MZJ5S713971, Serial Number MZJ5S713971; UDI 06934726614439-250623-MZJ5S714009, Serial Number MZJ5S714009