Fisher & Paykel Healthcare, Ltd.: Medical Device Recall in 2024 - (Recall #: Z-3262-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

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 sub-acute facilities.

Product Classification:

Class II

Date Initiated: August 7, 2024

Date Posted: October 2, 2024

Recall Number: Z-3262-2024

Event ID: 95173

Reason for Recall:

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.

Status: Ongoing

Product Quantity: 944 units

Code Information:

Model Number: PT301US UDI-DI code: 09420012466662 Lot/Serial Numbers:

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated