HIGH

Fisher & Paykel Recall 51,144 Airvo 2 and myAirvo 2 Humidifiers Over Power-Disconnect Audible Alert

Fisher & Paykel Healthcare recalled 51,144 Airvo 2 and myAirvo 2 humidifiers in the United States. The devices may emit an audible alert for less than 120 seconds after power is disconnected. This could delay user awareness to reconnect power and lead to oxygen desaturation. Patients and healthcare providers should stop using the device and await manufacturer instructions.

Quick Facts at a Glance

Recall Date
September 18, 2025
Hazard Level
HIGH
Brand
Fisher & Paykel Healthcare
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

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 You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Fisher & Paykel Healthcare, Ltd. or your healthcare provider for instructions. Notification method: Letter

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About This Product

Airvo 2 and myAirvo 2 humidifiers deliver high-flow warmed and humidified respiratory gases. They are used in clinical settings and, in some cases, home care if prescribed.

Why This Is Dangerous

The device may emit an audible alert for fewer than 120 seconds after losing power, delaying power reconnection and risking patient oxygen desaturation.

Industry Context

This recall is not described as part of a broader industry pattern.

Real-World Impact

Hospitals and clinics using these devices may experience brief alarm delays during power loss, requiring staff to verify power status promptly.

Practical Guidance

How to identify if yours is affected

  1. Confirm device model PT101US or PT100US.
  2. Check UDI-DI numbers: 9420012422347 and 9420012422248.
  3. Review Disinfection Kit Manual revision UI-185043723 Rev P.

Where to find product info

Refer to the FDA recall page and Fisher & Paykel Healthcare’s official channels for guidance.

What timeline to expect

No specific timeline is provided for remedies or replacements.

If the manufacturer is unresponsive

  • Document all communications with the manufacturer.
  • File a complaint with the FDA or relevant health agency if the company is unresponsive.

How to prevent similar issues

  • Regularly check recall databases for medical devices you own.
  • Verify model numbers before use.
  • Ensure power supplies are functional and within facility backup procedures.

Documentation advice

Keep recall notice, model numbers, UID codes, correspondence, and dates of any actions taken.

Product Details

Models PT101US (UDI-DI 9420012422347) and PT100US (UDI-DI 9420012422248) were recalled. The Disinfection Kit User Manual revision UI-185043723 rev P is part of the recall. Quantity: 51,144 units. Distribution: US nationwide. Recall date: 2025-09-18. Status: ACTIVE. Manufacturer: Fisher & Paykel Healthcare Ltd.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 51,144 units recalled
  • Audible alert under 120 seconds after power loss
  • PT101US and PT100US models
  • Disinfection Kit UI-185043723 rev P included
  • US nationwide distribution
  • Recall date 2025-09-18

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Details

Model Numbers
PT101US
PT100US
9420012422347
9420012422248
Affected States
ALL
Report Date
October 22, 2025
Recall Status
ACTIVE

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