FDA Medical Device Recalls (openFDA)
Fisher & Paykel Healthcare, Ltd.: Airvo 2, REF: PT101US, and myAirvo 2, REF: PT100US, used with Disinfection Kit User Manual, REF: UI-185043723
- Recall number
- Z-0158-2026
- Recalling firm
- Fisher & Paykel Healthcare, Ltd.
- Product
- Airvo 2, REF: PT101US, and myAirvo 2, REF: PT100US, used with Disinfection Kit User Manual, REF: UI-185043723
- Status
- Open, Classified
- Initiated
- 2025-09-18
- Posted
- 2025-10-15
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Nonconforming Material/Component
- Action
- On 9/18/2025, correction notices were communicated via email and phone call. Customers were asked to do the following: 1) Prior to use on a new patient, follow the instructions of the updated Disinfection Kit User Manual. 2) If you have distributed affected devices, notify your customers and include a copy of this notice. 3) Please report all device-related incidents to the firm, distributor or local representative. 3) Complete and return the response form via email to FieldActionUSCA@fphcare.com The Disinfection Kit User Manual updated to include: 7a: Perform Power-Out Alarm test Ensure steps 1-6 have been carried out, so that the alarm circuit is charged . Unplug the unit from the mains/utility power socket . Check that the audible alarm sounds for at least 120 seconds . The unit is now ready for storage . User Manuals can be downloaded from the following links: Airvo 2: https://resources.fphcare.com/content/airvo-manual-uk-us-and-az-ui-185045495-h-15thmarch22.pdf myAirvo 2: https://resources.fphcare.com/content/myairvo2-user-manual-ui-185045490.pdf Disinfection Kit: https://resources.fphcare.com/content/airvo-2-disinfection-manual-user-instructions-ui-185043723.pdf Please note, as per the "Technical Information" section of the Product Technical Manual and the User Manual, the expected service life is 5 years. If you have any questions, please contact the firm's Customer Care via email at FieldActionUSCA@fphcare.com or directly at +1 (800) 446 3908 ext 5003 or +1 (949) 453 4000 ext 5003.
- Quantity
- 51,144
- 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, 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.
- Lot, serial or model codes
- REF/UDI-DI: PT101US/9420012422347; PT100US/9420012422248. Disinfection Kit User Manual all revisions before UI-185043723 rev P
- 510(k) numbers
- ["K131895"]
- PMA numbers
- not on file
- Product code
- BTT
- Firm FEI
- 3002806988
- Firm city
- Auckland
- Firm state
- East Tamaki
- Firm country
- New Zealand
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28