The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Recalled Product
- 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 U.S.: 6,633, 173
- Date Initiated by Firm: December 6, 2023
Device Use
The Airlife Manual Resuscitator is a single patient use resuscitator intended for respiratory support.
Reason for Recall
Vyaire Medical, Inc. (Vyaire) is recalling certain AirLife Manual Resuscitators due to a manufacturing defect.
Using the recalled resuscitators could result in patients not receiving enough ventilation. In some cases, patients may not receive any ventilation. People who don’t get adequate ventilation may not be able to properly exchange oxygen and carbon dioxide (hypoventilation) or they could experience a drop in blood oxygen (hypoxia). These conditions can lead to serious injury or death.
There have been 37 reported incidents related to the recalled AirLife resuscitators, including two injuries and two deaths.
The issue was traced to a manufacturing defect that was corrected in 2017, but resuscitators distributed before the correction may still be in use.
Who May be Affected
Customers and distributors of Vyaire AirLife Manual Resuscitators.
What to Do
On January 10, 2024, Vyaire sent customers and distributors an urgent customer notification letter.
The letter asked customers with AirLife manual resuscitators impacted by the recall to:
- Discard or destroy the recalled AirLife manual resuscitators, and
- Complete a Certificate of Destruction Form and return it to Vyaire at productquality@myairlife.com.
Recalled resuscitators should not be returned to Vyaire.
Contact Information
Customers in the U.S. with questions about this recall should contact Vyaire Medical, Inc. at productquality@myairlife.com
Additional Resources:
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.
