Vyaire Medical recalls Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog Nu…

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.

On April 10, 2025, the firm notified customers via emailed letters titled URGENT: MEDICAL DEVICE RECALL. Customers are instructed to examine their inventory for the affected lots of product. Product in inventory should be quarantined. For in-use product - 1) For affected product in use that is utilizing the adaptor connection, immediately stop use of the product. 2) For affected product in use that is not utilizing the adaptor connection, ventilator circuit may continue to be utilized. Customers were provided with additional precautions to take to ensure proper function. Customers can choose between returning or destroying affected product. Firm will provide replacement product. If you have any questions regarding this field action, please call AirLife at 1-800-433-2797, or e-mail at productquality@myairlife.com.

• FDA enforcement recordOfficial FDA database entry for Z-1697-2025
• FDA 510(k) clearance · K151303The device's official FDA premarket clearance record
• FDA device classification · BZEOfficial FDA classification for this device type
• CFR regulation · 21 CFR 868.5270The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Vyaire MedicalSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.