Vyaire Medical: Medical Device Recall in 2018 - (Recall #: Z-0344-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Infant AirLife Dual-,limb, dual-heat, high-flow circuit (Model AH265) with AirLife Humidification Chamber, Model Number AH290. The AH290 Humidification Chamber and Heated Breathing Circuit Kit(s) operate as part of a system for delivering health and humidified respirator gasses to patients requiring invasive and non-invasive ventilation.

Product Classification:

Class I

Date Initiated: November 29, 2014

Date Posted: January 31, 2018

Recall Number: Z-0344-2018

Event ID: 78636

Reason for Recall:

Manufacturing error in humidification chamber may cause an overfill/overflow condition of the chamber. The may case a water back-up into the patient circuit resulting in an excessive amount of water entering the airway/lungs of the ventilated patient.

Status: Terminated

Product Quantity: 16,670 units in total

Code Information:

0001115635 0001115640 0001124941 0001124942 0001124943 0001124944 0001129628 0001134758 0001134759

Distribution Pattern:

US Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated