Official recall record
Airvo 2, REF: PT101US, and myAirvo 2, REF: PT100US, used with Disinfection Kit User Manual, REF: UI-185043723
- Issuing authority
- US FDA — Medical Devices
- Alert date
- 2025-09-18
- Country of alert
- New Zealand
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 9420012422347
- Brand on record
- Fisher & Paykel Healthcare, Ltd.
- Product category
- Medical Device
What the authority reported
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.
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.
Other recalls from this brand
- 2024-08-07 · US FDA — Medical Devices
PT301US Airvo 3 Respiratory Support Device with software version 1.2.0 and/or 1.5.1 The Airvo 3 is intende - 2024-04-02 · US FDA — Medical Devices
Airvo 2 Humidifier, REF: PT101US, and myAirvo 2 Humidifier, REF: PT100US
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