HIGH

Fisher & Paykel Healthcare Recalls Humidifier Devices Over Risk of Hypoxia

Fisher & Paykel Healthcare recalled 51,144 humidifier devices on September 18, 2025. The humidifiers may fail to alert users when disconnected from power, risking oxygen desaturation and hypoxia. Patients and healthcare providers should stop using the device immediately and follow recall 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

Product Details

The recalled products include Airvo 2, REF: PT101US, and myAirvo 2, REF: PT100US. These devices were distributed nationwide in the U.S. The disinfection kit user manual, REF: UI-185043723, has been updated to address the issue.

The Hazard

When disconnected from power, the humidifier may sound an alert for less than 120 seconds, delaying user awareness. This malfunction could lead to serious health risks, including oxygen desaturation and hypoxia.

Reported Incidents

No specific incidents or injuries have been reported in connection with this recall. The potential risk is significant due to the nature of the device.

What to Do

Stop using the humidifier immediately. Contact Fisher & Paykel Healthcare for further instructions and follow the recall guidelines provided in the notification letter.

Contact Information

For more information, contact Fisher & Paykel Healthcare at their customer service number or visit their website. Notification letters have been sent to affected users.

Key Facts

  • Recall date: September 18, 2025
  • Quantity recalled: 51,144 units
  • Affected models: PT101US, PT100US
  • Hazard classification: Class II
View Original Recall on FDA - Medical Devices

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Safety Assessment

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

Product Classification

Product TypeHumidifier Device
Sold At
Multiple Retailers

Product Details

Model Numbers
REF/UDI-DI: PT101US/9420012422347
PT100US/9420012422248. Disinfection Kit User Manual all revisions before UI-185043723 rev P
Affected States
ALL
Report Date
October 22, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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