Fisher & Paykel Healthcare recalls

3 official recalls and safety alerts involving Fisher & Paykel Healthcare since 2024-05, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Fisher & Paykel Healthcare or the relevant agency.

  1. 2025-10-22
  2. US
    Drugs & medicalClass II

    Fisher & Paykel Healthcare, Ltd. recalls Airvo 2, REF: PT101US, and myAirvo 2, REF: PT100US, used with Disinfection Kit User Manual, REF: UI-185043723

    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…

    FDA · DeviceFisher & Paykel Healthcare, Ltd.US Nationwide distribution including in the states of TX, MS, LA, NC, TN, NY,…Official notice →
  3. 2024-10-02
  4. US
    Drugs & medicalClass II

    Fisher & Paykel Healthcare, Ltd. recalls PT301US Airvo 3 Respiratory Support Device with software version 1.2.0 and/or 1.5.1 The Airvo 3 is intended to provide high…

    Due to a software issue, affected devices that are set up with High Pressure Oxygen (HPO), if the flow alignment alarm occurs, the device will deliver room air only. If this happens, a patient my experience oxygen…

    FDA · DeviceFisher & Paykel Healthcare, Ltd.U.S.: AZ, CA, CO, CT, DC, FL, GA, IA, IL, KY, MA, MD, MI, MN, MO, MT, ND, NH,…Official notice →
  5. 2024-05-22
  6. US
    Drugs & medicalClass II

    Fisher & Paykel Healthcare, Ltd. recalls Airvo 2 Humidifier, REF: PT101US, and myAirvo 2 Humidifier, REF: PT100US

    Humidifier devices, used to deliver high flow respiratory therapy to patients, manufactured before 14 August 2017, have a speaker configuration that may result in distorted, intermittent or inaudible alarm sound…

    FDA · DeviceFisher & Paykel Healthcare, Ltd.US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO,…Official notice →