Fisher & Paykel Healthcare recalls

Fisher & Paykel Healthcare has 7 recalls on record with the FDA and USDA, the earliest in 2013 and the latest reported on 22 Oct 2025. 3 are still ongoing. 1 was reported in the last 12 months. The most frequent reason is lead & heavy metals.

Total recalls7since 2013

Last 12 months1reported

Class I229% of total

Ongoing3latest 22 Oct 2025

Recalls per month, last 24 months

click a bar for that month

1Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 1Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 2 29%Class II 5 71%Class III 0 0%

Why fisher & paykel healthcare is recalled

Product types

Other Medical Devices457%
CPAP & Ventilators343%

By year

2025114%
2024229%
2014229%
2013229%

Ongoing fisher & paykel healthcare recalls

3 active

Reported	Class	Recall	Company	Reason	Where
22 Oct 2025Device	CLASS II	Airvo 2, REF: PT101US, and myAirvo 2, REF: PT100US, used recalled	Fisher & Paykel Healthcare	Lead & Heavy Metals	Nationwide
2 Oct 2024Device	CLASS II	PT301US Airvo 3 Respiratory Support Device recalled	Fisher & Paykel Healthcare	Lead & Heavy Metals	29 states
22 May 2024Device	CLASS II	Airvo 2 Humidifier recalled by Fisher & Paykel Healthcare	Fisher & Paykel Healthcare	Device Malfunction	Nationwide

All fisher & paykel healthcare recalls, newest first

7 total

Reported	Class	Recall	Company	Reason	Where
22 Oct 2025Device	CLASS II	Airvo 2, REF: PT101US, and myAirvo 2, REF: PT100US, used recalled	Fisher & Paykel Healthcare	Lead & Heavy Metals	Nationwide
2 Oct 2024Device	CLASS II	PT301US Airvo 3 Respiratory Support Device recalled	Fisher & Paykel Healthcare	Lead & Heavy Metals	29 states
22 May 2024Device	CLASS II	Airvo 2 Humidifier recalled by Fisher & Paykel Healthcare	Fisher & Paykel Healthcare	Device Malfunction	Nationwide
19 Nov 2014Device	CLASS II	(FPH) IW900-Series Infant Warmer Fisher and Paykel recalled	Fisher & Paykel Healthcare	Device Malfunction	Nationwide
28 May 2014Device	CLASS I	Infant Nasal CPAP (continuous positive airway pressure) Prong, Nasal recalled	Fisher & Paykel Healthcare	Other	Nationwide
5 Jun 2013Device	CLASS II	Icon CPAP (continuous positive airway pressure) recalled	Fisher & Paykel Healthcare	Other	Nationwide
9 Jan 2013Device	CLASS I	reusable breathing circuit recalled by Fisher & Paykel Healthcare	Fisher & Paykel Healthcare	Lead & Heavy Metals	4 states

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.