The Recall Desk

Manufacturer

Fisher & Paykel Healthcare, Ltd.

7 recalls in our database name Fisher & Paykel Healthcare, Ltd. as the manufacturing or recalling firm.

What the numbers show

Total
7
Critical
1
Severe
1
Most recent
2025-10-22

Of the 7 recalls from Fisher & Paykel Healthcare, Ltd. we have scored against our rubric, 1 (14%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (14%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–7 of 7

  • HighFDA (Devices)·Z-0158-2026·2025-10-22

    Humidifier devices recalled because power loss alert sounds under two minutes

    Fisher & Paykel is recalling 51,144 Airvo 2 and myAirvo 2 humidifiers because an unintentional power disconnection may sound an audible alert for less than 120 seconds.

    Product
    Airvo 2, REF: PT101US, and myAirvo 2, REF: PT100US, used with Disinfection Kit User Manual, REF: UI-185043723
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3262-2024·2024-10-02

    Airvo 3 Respiratory Device Recalled for Software Issue Affecting Oxygen Delivery

    Fisher & Paykel's Airvo 3 respiratory device has a software defect that may cause it to deliver only room air instead of oxygen during certain alarm conditions, potentially causing oxygen desaturation and hypoxia in patients.

    Product
    PT301US Airvo 3 Respiratory Support Device with software version 1.2.0 and/or 1.5.1 The Airvo 3 is intended to provide high flow warmed and humidified respiratory gases for administration to spontaneously breathing infant, child, adolescent and adult patients in hospitals and
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-1823-2024·2024-05-22

    Airvo 2 and myAirvo 2 Humidifiers: Alarm Speaker Defect Recall

    Fisher & Paykel's Airvo 2 and myAirvo 2 respiratory humidifiers have a speaker defect that may silence or distort critical alarm sounds. If the alarm fails and therapy is interrupted, patients could experience oxygen desaturation.

    Product
    Airvo 2 Humidifier, REF: PT101US, and myAirvo 2 Humidifier, REF: PT100US
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0210-2015·2014-11-19

    Fisher and Paykel Infant Warmer Recall Due to Heater Head Breakage

    Fisher and Paykel Healthcare is recalling IW900-Series Infant Warmers and spare parts because a broken nut may allow the heater head to swing and injure infants.

    Product
    Fisher and Paykel Healthcare (FPH) IW900-Series Infant Warmer Fisher and Paykel; Healthcare CosyCot and Kit Replacement Head Case Assembly It is designed to assist with the thermoregulation of infants weighing up to 10kg and is used by labor and delivery rooms and pediatric
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1539-2014·2014-05-28

    Fisher & Paykel Recalls Infant Nasal CPAP Prongs for Detachment Risk

    Fisher & Paykel Healthcare is recalling infant nasal CPAP prongs and starter kits because the prongs may detach from the tubing, interrupting therapy.

    Product
    Infant Nasal CPAP (continuous positive airway pressure) Prong, Nasal. CPAP Prongs (10 pack): Model No. BC3020-10, BC3520-10, BC4030-10, BC4540-10, BC5040-10, BC5050-10, BC5550-10, BC5560-10, BC6060-10, BC6070-10, BC6570-10. Bubble CPAP Starter Kits: Model No. BC461-SK, BC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1437-2013·2013-06-05

    Fisher & Paykel Recalls ICON CPAP Units Due to Power Issue

    Fisher & Paykel Healthcare is recalling 1,407 ICON CPAP units because they may become inoperable, interrupting treatment for obstructive sleep apnea.

    Product
    Fisher & Paykel Healthcare ICON CPAP (continuous positive airway pressure). Models: ICON Auto: ICONAAN, ICONAAN-HT, ICONAAJ. ICON Novo: ICONNAN, ICONNAN-HT, ICONNAJ. ICON Premo: ICONPBN, ICONPBN-HT, ICONPBN-HTC. The ICON CPAP unit is for use on adult patients for t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0621-2013·2013-01-09

    Fisher & Paykel Healthcare Recalls Reusable Breathing Circuits Due to Hole Damage

    Fisher & Paykel Healthcare is recalling specific lots of reusable breathing circuits because tube hole damage could cause gas leaks and loss of pressure during oxygen therapy.

    Product
    Fisher & Paykel Healthcare reusable breathing circuit. Non-heated breathing circuit, 1.8m or 6 feet in length. Oxygen therapy delivery system for adult patient.
    Category
    Medical Device
    Distribution
    4 states

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Fisher & Paykel Healthcare

New Zealand public company

Country
New Zealand
Founded
1957

Official website

Source: Wikidata (Q5454753), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.