Vyaire Medical: Device Recall

Recall #Z-1698-2025 · 04/10/2025

Class I: Dangerous

Recall Details

Recall Number: Z-1698-2025
Classification: Class I
Product Type: Device
Recalling Firm: Vyaire Medical
Status: Ongoing
Date Initiated: 04/10/2025
Location: Mettawa, IL, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 3053

Reason for Recall

Adapters may disconnect during setup or while in use, potentially interrupting ventilation. Any disconnection can result in severe consequences for neonates, including hypoxia, hypercapnia, and organ failure.

Product Description

Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog Number: AH265 Software Version: N/A Product Description: AirLife Infant Heated Wire Circuit Kit Dual-limb, Dual-heat, high-flow circuit (>4 L/min) Contains AH165 Circuit, AH290 Chamber Component: No. a conduit for respiratory gas between the patient and a ventilator.

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Germany, Poland, Belgium, Spain, Romania, UK, Italy, Netherlands, India, Slovenia, Qatar, and Saudi Arabia.

Other Recalls by Vyaire Medical

Class I: Dangerous 04/10/2025

Adapters may disconnect during setup or while in use, potentially interrupting ventilation. Any disconnection can result in severe consequences for neonates, including hypoxia, hypercapnia, and organ failure.

View all recalls by Vyaire Medical →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.