BEUDAMED
    FDA Enforcement Class II Ongoing

    Airvo 2, REF: PT101US, and myAirvo 2, REF: PT100US, used with Disinfection Kit User Manual, REF: UI-185043723

    Recall: Z-0158-2026 · Reported October 22, 2025

    Enforcement

    Recall Number
    Z-0158-2026
    Event ID
    97591
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Fisher & Paykel Healthcare, Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 22, 2025
    Initiation Date
    September 18, 2025
    Classification Date
    October 15, 2025
    Address
    15 Maurice Paykel Place, East Tamaki, Auckland, N/A, New Zealand

    Description

    Airvo 2, REF: PT101US, and myAirvo 2, REF: PT100US, used with Disinfection Kit User Manual, REF: UI-185043723

    Reason

    When unintentionally disconnected from power source, humidifier device (used to deliver high flow warmed and humidified respiratory gases) may sound audible alert for less than 120 seconds, which may delay user awareness to reconnect power, which could lead to oxygen desaturation, hypoxia. Disinfection kit user manual updated to include checking the audible alert prior to use on a new patient.

    Code Info

    REF/UDI-DI: PT101US/9420012422347; PT100US/9420012422248. Disinfection Kit User Manual all revisions before UI-185043723 rev P

    Distribution

    US Nationwide distribution including in the states of TX, MS, LA, NC, TN, NY, FL, IL, UT, MT, OH, MI, NJ, AR, GA, WI, CA, IN, OK, CO, AL, SC, AZ, MD, WA, MO, PA, MA, NH, KY, KS, VA, CT, MN, ND, NM, NE, IA, WV, ID, NV, OR, HI, VT, RI, AL, SD, WY, PR, ME.

    Quantity

    51,144