Fisher & Paykel Healthcare Limited

Also registered as Fisher and Paykel Healthcare Limited

New ZealandFDA applicant, unverified

Devices: 1
FDA recalls: 63 ongoing

At a glance

Counted by deviCERTS from registry records

Market reach

United States: FDA recalls

Catalogue1

Newest first, rows 1-1 of 1

Optiflow Oxygen Kit (AA484J) Ref K262268

Active Regimes: 510(k) Registry: 510(k) Class:II

FDA recalls6

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

Recalls initiated per year

2017 0
2018 0
2019 0
2020 0
2021 0
2022 0
2023 0
2024 2
2025 1
2026 0

3 initiated before 2017

2025
- 18 Sep 2025 Z-0158-2026 Class II Ongoing 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. Distribution: US Nationwide distribution including in the states of TX, MS, LA, NC, TN, NY, FL, IL, UT, MT, OH, MI, NJ, AR, GA, WI,…
  Full distribution text
  US Nationwide distribution including in the states of TX, MS, LA, NC, TN, NY, FL, IL, UT, MT, OH, MI, NJ, AR, GA, WI, CA, IN, OK, CO, AL, SC, AZ, MD, WA, MO, PA, MA, NH, KY, KS, VA, CT, MN, ND, NM, NE, IA, WV, ID, NV, OR, HI, VT, RI, AL, SD, WY, PR, ME.
  Submission number: K131895
2024
- 7 Aug 2024 Z-3262-2024 Class II Ongoing 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. Distribution: U.S.: AZ, CA, CO, CT, DC, FL, GA, IA, IL, KY, MA, MD, MI, MN, MO, MT, ND, NH, NJ, NV, NY, OH, OR, PA, SD, TX, UT, VA and…
  Full distribution text
  U.S.: AZ, CA, CO, CT, DC, FL, GA, IA, IL, KY, MA, MD, MI, MN, MO, MT, ND, NH, NJ, NV, NY, OH, OR, PA, SD, TX, UT, VA and WA. O.U.S.: Not provided
  Submission number: K221338
- 2 Apr 2024 Z-1823-2024 Class II Ongoing 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. Distribution: US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS,…
  Full distribution text
  US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.
  Submission number: K131895
2014
- 6 Nov 2014 Z-0210-2015 Class II Terminated 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. Distribution: Worldwide Distribution - USA (nationwide) and Internationally to Albania, Algeria, Australia, Austria, Bahrain,…
  Full distribution text
  Worldwide Distribution - USA (nationwide) and Internationally to Albania, Algeria, Australia, Austria, Bahrain, Bangladesh, Bekgium, Bermuda, Chile, China, Croatia, Dominican Republic, Estonia, Finland, France, Germany, Great Britain, Greece, Hong Kong, Iceland, India, Indonesia, Iran, Ireland, Israel, Jordan, Kenya, Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Mauritius, Mexico. Morocco, New Zealand, Nigeria, Northern Ireland, Norway, Pakistan, Palestinian Territory, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, singapore, Slovenia, South Africa, Spain, Sri Lanka, Sultanate of Oman, Syria, Taiwan, Thailand, The Netherlands, Tunisia, Turkey, United Arab Emirates, Uruguay, Venezuela, Vietnam, and West Bank.
  Submission numbers: K970432, K971461
- 15 Apr 2014 Z-1539-2014 Class I Terminated The Infant Nasal CPAP Prong has the potential to detach from the Nasal Tubing and therapy is likely to be interrupted. Distribution: Worldwide Distribution - USA (nationwide) and Internationally to: ARGENTINA AUSTRALIA BANGLADESH BELGIUM CANADA CHILE…
  Full distribution text
  Worldwide Distribution - USA (nationwide) and Internationally to: ARGENTINA AUSTRALIA BANGLADESH BELGIUM CANADA CHILE CHINA FRANCE GERMANY GREAT BRITAIN GREECE HUNGARY INDIA INDONESIA IRAQ ISRAEL ITALY JAPAN LIBYA MALAYSIA NEPAL NETHERLANDS NEW ZEALAND PERU POLAND PORTUGAL QATAR ROMANIA RUSSIA RWANDA SAUDI ARABIA SOUTH AFRICA SPAIN SRI LANKA SWITZERLAND TAIWAN THAILAND TRINIDAD & TOBAGO TURKEY UNITED ARAB EMIRATES
2006
- 9 Oct 2006 Z-0485-2007 Unclassified (pre-2012) Terminated This firm has received Product Complaint Reports concerning bending of the pivot plate. The elevator base of the CosyCot Infant Warmer incorporates a pivot plate which forms part of the mechanism allowing the CosyCot to raise and lower in height. A bent pivot plate generally results in the Warmer being unable to elevate properly. Other component failures may result. Distribution: Nationwide and Canada Submission number: K970432

Frequently asked questions

How many devices does Fisher & Paykel Healthcare Limited have in the registry?

The registry currently lists 1 device for Fisher & Paykel Healthcare Limited. Devices recorded under merged duplicate company entries are counted once.

Which registries list Fisher & Paykel Healthcare Limited's devices?

Among its 1 most recently registered device, Fisher & Paykel Healthcare Limited has devices listed in FDA 510(k) (1 device).

What risk classes do Fisher & Paykel Healthcare Limited's devices fall under?

Among its 1 most recently registered device, the classes recorded for Fisher & Paykel Healthcare Limited's devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Fisher & Paykel Healthcare Limited?

FDA recall records list 6 recalls initiated by Fisher & Paykel Healthcare Limited, the most recent initiated on 18 Sep 2025. 3 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Fisher & Paykel Healthcare Limited in the registry?

The most recently registered devices listed for Fisher & Paykel Healthcare Limited include Optiflow Oxygen Kit (AA484J).

Generated automatically from registry data and not verified by a human reviewer.