Fisher & Paykel Healthcare, Ltd. FDA Recalls

3 recalls on file across devices, 0 of them Class I and 3 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Airvo 2, REF: PT101US, and myAirvo 2, REF: PT100US, used with Disinfection Kit User Manual, REF: UI-185043723Class IISep 18, 2025When unintentionally disconnected from power source, humidif	When unintentionally disconnected from power source, humidifier device (used to deliver high flow warmed and h	Class IIDevices	Sep 18, 2025
PT301US Airvo 3 Respiratory Support Device with software version 1.2.0 and/or 1.5.1 The Airvo 3 is intended to proviClass IIAug 7, 2024Due to a software issue, affected devices that are set up wi	Due to a software issue, affected devices that are set up with High Pressure Oxygen (HPO), if the flow alignme	Class IIDevices	Aug 7, 2024
Airvo 2 Humidifier, REF: PT101US, and myAirvo 2 Humidifier, REF: PT100USClass IIApr 2, 2024Humidifier devices, used to deliver high flow respiratory th	Humidifier devices, used to deliver high flow respiratory therapy to patients, manufactured before 14 August 2	Class IIDevices	Apr 2, 2024