Vyaire Medical Inc is recalling certain AirLife manual resuscitators for a manufacturing defect that could lead to injury or death, according to the FDA. The recall is classified as Class I.

The FDA recall alert reports that using the recalled resuscitators could result in patients not receiving enough ventilation, and in some cases, patients may not receive any ventilation. Patients who don’t get adequate ventilation may experience hypoventilation or hypoxia, which can lead to serious injury or death, the FDA reports.

According to the FDA, there have been 37 reported incidents related to the recalled AirLife resuscitators, including two injuries and two deaths. The agency says the issue was traced to a manufacturing defect that was corrected in 2017, but resuscitators distributed before the correction may still be in use.

Recalled Products 

  • Product Names and Codes:
    • AirLife™ Adult Manual Resuscitator, Oxygen Reservoir Bag, without Mask, 2K8000 
    • AirLife™ Adult Manual Resuscitator, 40″ (1.0m) Oxygen Reservoir Tubing, without Mask, 2K8001 
    • AirLife™ Adult Manual Resuscitator, Oxygen Reservoir Bag, Expiratory Filter, 2K8004F 
    • AirLife™ Adult Manual Resuscitator, Oxygen Reservoir Bag, Adult Mask, CO2 Detector, 2K8004C2 
    • AirLife™ Adult Manual Resuscitator, 40″ (1.0m) Oxygen Reservoir Tubing, Adult Mask, 2K8005 
    • AirLife™ Adult Manual Resuscitator, 40″ (1.0m) Oxygen Reservoir Tubing, Adult Mask, Expiratory Filter, 2K8005F 
    • AirLife™ Adult Manual Resuscitator, 40″ (1.0 m) Oxygen Reservoir Tubing, Adult Mask, CO2 Detector, 2K8005C2 
    • AirLife™ Adult Manual Resuscitator, Variable Volume Oxygen Reservoir Tubing, Adult Mask, 2K8017 
    • AirLife™ Adult Manual Resuscitator, 40″ (1.0m) Oxygen Reservoir Tubing, Adult Mask, 2K8004 
  • Manufacturing Dates: 2017 or earlier and products without a manufacturing date
  • Devices Recalled in the US: 6,633, 173
  • Date Initiated by Firm: December 6, 2023  

The AirLife brand of products was acquired from Vyaire in May 2023 by SunMed, which rebranded its company as “AirLife” in September 2023. The products subject to this recall are those manufactured in 2017 or earlier, the FDA noted.

The FDA directs US customers to contact Vyaire Medical Inc at [email protected].

Source: FDA