BEUDAMED
    FDA Enforcement Class II Ongoing

    React Health PHOENIX 5L Oxygen Concentrator

    Recall: Z-1815-2026 · Reported April 22, 2026

    Enforcement

    Recall Number
    Z-1815-2026
    Event ID
    98563
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    3B Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 22, 2026
    Initiation Date
    February 4, 2026
    Classification Date
    April 15, 2026
    Address
    5475 Rings Rd Ste 550, N/A, Dublin, OH, 43017-7537, United States

    Description

    React Health PHOENIX 5L Oxygen Concentrator

    Reason

    Devices which did not meet internal quality specifications were inadvertently distributed.

    Code Info

    UDI 06934726614439-250623-MZJ5S713971, Serial Number MZJ5S713971; UDI 06934726614439-250623-MZJ5S714009, Serial Number MZJ5S714009

    Distribution

    US Nationwide distribution in the state of NY.

    Quantity

    2 units