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Fisher & Paykel Healthcare Recalls
7 recalls on record · January 9, 2013 to October 22, 2025 · Medical Devices
Recalls by year
13
14
24
25
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
October 22, 2025Medical DevicesFDA
Fisher & Paykel Healthcare, Ltd. recalls Airvo 2, REF: PT101US, and myAirvo 2, REF: PT100US, used with Disinfection Kit User Manual, REF: UI-185043723
Hazard: 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.
October 2, 2024Medical DevicesFDA
Fisher & Paykel Healthcare, Ltd. recalls PT301US Airvo 3 Respiratory Support Device with software version 1.2.0 and/or 1.5.1 The Airvo 3 is intended to provi
Hazard: Due to a software issue, affected devices that are set up with High Pressure Oxygen (HPO), if the flow alignment alarm occurs, the device will deliver room air only. If this happens, a patient my experience oxygen desaturation that could lead to hypoxia.
May 22, 2024Medical DevicesFDA
Fisher & Paykel Healthcare, Ltd. recalls Airvo 2 Humidifier, REF: PT101US, and myAirvo 2 Humidifier, REF: PT100US
Hazard: Humidifier devices, used to deliver high flow respiratory therapy to patients, manufactured before 14 August 2017, have a speaker configuration that may result in distorted, intermittent or inaudible alarm sound levels. In the absence of an audible alarm, if there is an interruption to therapy, a patient may experience oxygen desaturation.
November 19, 2014Medical DevicesFDA
Fisher & Paykel Healthcare, Ltd. recalls Fisher and Paykel Healthcare (FPH) IW900-Series Infant Warmer Fisher and Paykel; Healthcare CosyCot and Kit Replaceme
Hazard: Breakage of the nut that secures the heater head in place, which can cause the heater head to become partially detached and swing towards the bassinet. There is the potential that a heater head could contact a patient situated on the bassinet and cause a serious injury.
May 28, 2014Medical DevicesFDA
Fisher & Paykel Healthcare, Ltd. recalls Infant Nasal CPAP (continuous positive airway pressure) Prong, Nasal. CPAP Prongs (10 pack): Model No. BC3020-10, BC
Hazard: The Infant Nasal CPAP Prong has the potential to detach from the Nasal Tubing and therapy is likely to be interrupted.
June 5, 2013Medical DevicesFDA
Fisher & Paykel Healthcare, Ltd. recalls Fisher & Paykel Healthcare ICON CPAP (continuous positive airway pressure). Models: ICON Auto: ICONAAN, ICONAAN-
Hazard: Fisher and Paykel Healthcare is recalling the ICON CPAP units because there is a potential power issue on certain ICON CPAP. These ICON CPAP units could potentially become inoperable, which would result in a lack of treatment to the patient's obstructive sleep apnea symptoms until a replacement unit is obtained.
January 9, 2013Medical DevicesFDA
Fisher & Paykel Healthcare, Ltd. recalls Fisher & Paykel Healthcare reusable breathing circuit. Non-heated breathing circuit, 1.8m or 6 feet in length. Oxyge
Hazard: FPH has become aware that one batch of tubes supplied to FPH may contain hole damage. These tubes were incorporated by FPH into certain 900MR068 reusable circuits with lot numbers 110810 and 111020. If this hole damage is not detected during the standard leak test before patient use, it could potentially result in a gas leak in the breathing system, which may lead to a loss of pressure for the int