AirLife Manual Resuscitator Recall Issued Following Reports of Injuries and Deaths

A recall has been issued for millions of AirLife Manual Resuscitators, following numerous incidents where the devices failed to work properly, resulting in patients not receiving adequate breathing support, and suffering severe or fatal injuries.

The U.S. Food and Drug Administration (FDA) announced the AirLife Manual Resuscitators recall on March 21, indicating that a manufacturing error could result in patents not receiving enough ventilation, or in more serious cases not receiving any ventilation at all.

AirLife Manual Resuscitators are used to resuscitate a single patient who is unconscious or not breathing, and in need of respiratory support. Vyaire Medical, Inc., the manufacturer of the device, indicates that it is aware of at least 37 incident reports, including two reports of injury and two reports of death linked to the defect.

The FDA has given the recall a Class I designation, meaning the agency believes problems with the manual resuscitators pose a serious risk of injury and death for patients. The problem with the resuscitators was corrected back in 2017, but the FDA warns that numerous devices are likely still in use nationwide.

AirLife Manual Resuscitator Recall

Approximately 6,633,173 manual resuscitators are impacted by the recall, each of which contain the product name AirLife Adult Manual Resuscitator.

Vyaire Medical issued an urgent notification letter regarding the problem on January 10, warning customers to discard or destroy the recalled manual resuscitators, and complete a certificate of destruction form and return it to Vyaire at productquality@myairlife.com.

For more information, consumers can contact Vyaire Medical, Inc. at productquality@myairlife.com. For any adverse reactions or quality problems consumers can also use the FDA’s MedWatch Adverse Event Reporting program either online, by mail or by fax.