FDA recall record · openFDA

Fisher & Paykel Healthcare, Ltd.

3 FDA recalls on record (2024–2025) — 3 device. 3 still ongoing.

Class I (most serious)

Class II

Class III

ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

Due to a software issue, affected devices that are set up with High Pressure Oxygen (HPO), if the flow alignment alarm o 1

Humidifier devices, used to deliver high flow respiratory therapy to patients, manufactured before 14 August 2017, have 1

When unintentionally disconnected from power source, humidifier device (used to deliver high flow warmed and humidified 1

Recalls

Airvo 2, REF: PT101US, and myAirvo 2, REF: PT100US, used with Disinfection Kit User Manual, REF: UI-185043723 Class II 2025-09-18 PT301US Airvo 3 Respiratory Support Device with software version 1.2.0 and/or 1.5.1 The Airvo 3 is intended to provi Class II 2024-08-07 Airvo 2 Humidifier, REF: PT101US, and myAirvo 2 Humidifier, REF: PT100US Class II 2024-04-02

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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