Official recall record
Airvo 2 Humidifier, REF: PT101US, and myAirvo 2 Humidifier, REF: PT100US
- Issuing authority
- US FDA — Medical Devices
- Alert date
- 2024-04-02
- Country of alert
- New Zealand
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 09420012422248
- Brand on record
- Fisher & Paykel Healthcare, Ltd.
What the authority reported
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 levels. In the absence of an audible alarm, if there is an interruption to therapy, a patient may experience oxygen desaturation.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
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Airvo 2, REF: PT101US, and myAirvo 2, REF: PT100US, used with Disinfection Kit User Manual, REF: UI-185043723 - 2024-08-07 · US FDA — Medical Devices
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