Vyaire Medical: Medical Device Recall in 2018 - (Recall #: Z-0346-2018)

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:

Adult AirLife dual-limb, dual-heat circuit (Model AH280) 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-0346-2018

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:

0001100127 0001116871 0001116872 0001124936 0001129065 0001129066 0001129067 0001129069 0001129070 0001131426 0001131428 0001134350 0001135400 0001136027 0001136028 0001136029 0001145151 0001145152 0001145153 0001157125

Distribution Pattern:

US Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated