Vyaire Medical Recalls AirLife Manual Resuscitators

Vyaire Medical recently announced the recall of certain AirLife Manual Resuscitators due to a reported manufacturing defect. The AirLife device is a single patient use resuscitator intended for respiratory support.

Not disclosing the specific defect, the company said that the issue was traced back to 2017, when it was ultimately corrected. However, Vyaire posited that resuscitators distributed in 2017 or earlier, as well as products without a manufacturing date, may still be in use.

Using a recalled resuscitator, according to the recall notice, could result in patients not receiving enough ventilation, or any ventilation at all. When this happens, patients may not be able to adequately exchange oxygen and carbon dioxide or could experience a drop in blood oxygen, leading to serious injury or death.

There have been 37 reported incidents related to the recalled devices, including two injuries and two deaths. Currently, over six million devices have been recalled in connection with the notice.

Initially sending customers and distributors an urgent customer notification on Jan. 10, Vyaire asked those impacted by the recall to discard or destroy the recalled AirLife manual resuscitators and complete a Certificate of Destruction form that would be sent to the company. The recalled resuscitators themselves should not be returned to Vyaire.

Becton, Dickinson and Company (BD) created Vyaire in 2016 as a joint venture and then sold its stake in 2018. In 2023, Vyaire sold the AirLife portfolio and the rest of its respiratory and anesthesia consumables business to Sunmed — now rebranded as AirLife.

AirLife did not respond to MD+DI’s request for comment.