Vyaire Medical: Medical Device Recall in 2025 - (Recall #: Z-1697-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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

Product Classification:

Class I

Date Initiated: April 10, 2025

Date Posted: May 21, 2025

Recall Number: Z-1697-2025

Event ID: 96664

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.

Status: Ongoing

Product Quantity: 1895

Code Information:

Lot Code: Lot/Serial Number(s): 0004240347 0004240348 0004252021 0004253194 0004253470 0004255176 0004260100 0004262183 0004262987 0004263371 0004292077 0004300092 0004301668 UDI-DI AirLife Label Each: 10889483595862 Case: 30889483595866 Vyaire Label Each: 10190752145139 Case: 50190752145137

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated