Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
PT301US Airvo 3 Respiratory Support Device with software version 1.2.0 Recalled by Fisher & Paykel Healthcare, Ltd. Due to Due to a software issue, affected devices that...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Fisher & Paykel Healthcare, Ltd. directly.
Affected Products
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.
Quantity: 944 units
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 29 states: AZ, CA, CO, CT, FL, GA, IL, IA, KY, MD, MA, MI, MN, MO, MT, NV, NH, NJ, NY, ND, OH, OR, PA, SD, TX, UT, VA, WA, DC
About Fisher & Paykel Healthcare, Ltd.
Fisher & Paykel Healthcare, Ltd. has 7 total recalls tracked by RecallDetector.
Related Recalls
EndoVive Safety PEG Kit Recalled by Boston Scientific Corporation Due to Recall of kits which utilized ChloraPrep Triple Swabsticks...
Boston Scientific Corporation · February 10, 2026
Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...
Trividia Health, Inc. · February 6, 2026
Artelon FlexBand Dynamic Matrix Ref: 31057 Recalled by International Life Sciences Due to Augmentation devices failed bacterial endotoxin testing.
International Life Sciences · February 6, 2026
Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...
Trividia Health, Inc. · February 6, 2026
Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...
Trividia Health, Inc. · February 6, 2026
Data sourced from the FDA (Device). Last updated March 26, 2026. View original report