Fisher & Paykel Healthcare, Ltd.
FDA Regulatory Profile
Summary
- Total Recalls
- 7 (2 Class I)
- 510(k) Clearances
- 70
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0158-2026 | Class II | Airvo 2, REF: PT101US, and myAirvo 2, REF: PT100US, used with Disinfection Kit User Manual, REF: UI- | September 18, 2025 |
| Z-3262-2024 | Class II | PT301US Airvo 3 Respiratory Support Device with software version 1.2.0 and/or 1.5.1 The Airvo 3 | August 7, 2024 |
| Z-1823-2024 | Class II | Airvo 2 Humidifier, REF: PT101US, and myAirvo 2 Humidifier, REF: PT100US | April 2, 2024 |
| Z-0210-2015 | Class II | Fisher and Paykel Healthcare (FPH) IW900-Series Infant Warmer Fisher and Paykel; Healthcare CosyC | November 6, 2014 |
| Z-1539-2014 | Class I | Infant Nasal CPAP (continuous positive airway pressure) Prong, Nasal. CPAP Prongs (10 pack): Mod | April 15, 2014 |
| Z-1437-2013 | Class II | Fisher & Paykel Healthcare ICON CPAP (continuous positive airway pressure). Models: ICON Auto | April 22, 2013 |
| Z-0621-2013 | Class I | Fisher & Paykel Healthcare reusable breathing circuit. Non-heated breathing circuit, 1.8m or 6 feet | November 19, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K253479 | Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J) | December 19, 2025 |
| K250651 | OptiPAP Junior Flexi Tube US (OPTIPAPFUS); OptiPAP Junior Nasal Prongs XXS (OPTIPAPPXXS); OptiPAP Ju | November 19, 2025 |
| K252173 | F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size A (ONIV117A); | September 10, 2025 |
| K243917 | F&P Optiflow Air/Oxygen Flow Source | July 14, 2025 |
| K251611 | Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944); Optiflow+ Nasa | June 25, 2025 |
| K233643 | F&P Airvo 3 NIV (PT311US) | August 9, 2024 |
| K234053 | F&P Optiflow Flow Diverter | August 9, 2024 |
| K234058 | F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J) | August 8, 2024 |
| K233821 | F&P Optiflow Oxygen Kit (AA451J) | June 13, 2024 |
| K231956 | F&P Optiflow+ Duet Nasal Cannula | February 7, 2024 |
| K223684 | F&P 820 Humidification System | September 5, 2023 |
| K221436 | F&P 950 Accessory Breathing Circuit Kits | June 29, 2023 |
| K223696 | F&P Solo Mask Range | May 17, 2023 |
| K222197 | F&P Optiflow Junior 2/2+ Nasal Cannula Interface Range | April 6, 2023 |
| K212031 | F&P 850 AirSpiral Adult NIV and NHF Circuit Kit | April 22, 2022 |
| K212371 | F&P Evora Full Face Mask | March 18, 2022 |
| K211096 | Optiflow Oxygen Kit | January 28, 2022 |
| K203449 | F&P Visairo NIV Mask Range | April 14, 2021 |
| K201723 | F&P Optiflow Nasal Oxygen Cannula with CO2 Sampling | March 16, 2021 |
| K200089 | F&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack | June 2, 2020 |