AirLife/Vyaire Infant Breathing Systems Recall

Potential for risk of disconnection

Class I Recall

AirLife and manufacturer Vyaire are recalling specific Infant Heated Wire Circuits due to the risk that accessory adapters may disconnect during use, especially once the system reaches operating temperature. This could lead to serious injury or death, including hypoxia, hypercapnia, organ failure, and respiratory collapse.

The FDA has classified this as a Class I recall, the most serious type.

Device Use

These circuits are used to warm breathing gases during mechanical ventilation in neonatal and infant patients, connecting the ventilator to the airway.

Affected Products

  • AirLife and Vyaire Infant Heated Wire Circuit AH165 and kits with AH265 chamber
  • High-flow dual-limb, dual-heat systems (>4 L/min)
  • Full UDI details are listed in the FDA’s Medical Device Recall Database

What You Should Do

  • Do NOT use the accessory adapter connections from affected circuit kits.
  • Stop using any devices currently using these adapters.
  • Devices may still be used if adapter connections are not installed.
  • Quarantine affected products, notify relevant staff, and perform regular system checks.
  • Activate all ventilator alarms and monitor respiratory parameters closely.
  • Ensure backup ventilation/resuscitation equipment is available at bedside.
  • Test circuits before use for leaks.
  • Return the completed Response Form and notify any customers who received the affected products.
  • For urgent needs, call AirLife at 1-800-433-2797 or email: productquality@myairlife.com

This recall is a critical safety action to protect vulnerable infant patients from potential airway disconnection and respiratory failure. Prompt inventory review and staff notification are essential. 

 

Affected Products

Affected Lot Numbers

Product Description Individual UDI Case UDI
AirLife Infant Heated Wire Circuit dual-limb dual-heat, highflow circuit (>4L/min)/AH165 (AirLife) 10889483595862 30889483595866
AirLife Infant Heated Wire Circuit dual-limb dual-heat, highflow circuit (>4L/min)/AH165 (Vyaire) 10190752145139 50190752145137
AirLife Infant Heated Wire Circuit Kit Dual-limb, Dual-heat, high-flow circuit (>4 L/min), Contains AH165 and Circuit, AH290 Chamber/AH265 (AirLife) 10889483595909 30889483595903
AirLife Infant Heated Wire Circuit Kit Dual-limb, Dual-heat, high-flow circuit (>4 L/min), Contains AH165 and Circuit, AH290 Chamber/AH265 (Vyaire) 10190752145160 50190752145168

News

FDA Enforcement

Safety Alerts

Medical Devices

Pharma

New Drugs

Drug Shortages

QMSR Clause 6 – Resource Management

Ensuring the Organization Has the Capability to Deliver Safe and Effective Medical Devices Clause 6 of ISO 13485:2016 defines the requirements for providing and managing the resources necessary to implement, maintain, and improve a quality management system. At its...

The Role of a Regulatory Professional

510(k) Submissions The New QSMR Regulatory Intelligence RIM Systems Regulatory Competencies Regulatory and Quality Role of Regulatory Professionals: Core Responsibilities Regulatory professionals play a critical role in ensuring that medical devices and pharmaceutical...

Urgent Recall: Dr. Reddy’s Levetiracetam Injection

What You Need to Know Dr. Reddy’s Laboratories has issued an urgent recall for one batch (Lot No: A1540076) of Levetiracetam in 0.75% Sodium Chloride Injection, 1,000 mg/100 mL due to a serious labeling error. The infusion bag is incorrectly labeled as Levetiracetam...