AirLife Manual Resuscitator Recall  – Class Action Investigation

CSK&D is investigating a potential class action lawsuit against Vyaire Medical, Inc. (“Vyaire”) related to an alleged safety defect affecting AirLife resuscitators used in emergency situations to provide respiratory support to patients. Vyaire has issued a recall of these devices due to a manufacturing defect that can lead to inadequate ventilation when in use by patients. If patients do not receive sufficient ventilation, they may suffer from hypoxia, a lack of oxygen and/or hypoventilation due to heightened levels of carbon dioxide levels.

The U.S. Food and Drug Administration designated the recall as Class 1, the most serious category of recall, due to the determination that use of the recalled devices carries a high risk of causing serious injury or death. An estimated 6.6 million devices were manufactured in or before 2017, and stocked in hospitals, ambulances, and healthcare facilities across the country.

The recall includes the following resuscitators:

  • 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

Hospitals, healthcare facilities, and ambulance companies that purchased these devices are being asked to immediately discontinue use of these devices and discard and destroy them. Vyaire has not provided any way for purchasers of these devices to return them nor to receive compensation for the unsafe devices.

If you are a hospital, medical practice, or ambulance company that owns one of the products affected by the recall, please fill out the form below.

Airlife Manual Resuscitator Recall (#377)

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