FDA hands Class I label to recall of 6.6M Vyaire bag valve masks

The FDA is getting the word out on an ongoing recall of millions of hand-powered bag valve masks, which may not deliver enough oxygen to a patient in need of resuscitation.

The disposable emergency devices, stocked in ambulances and kept at hospital bedsides, are used to force air into the lungs to help counter insufficient breathing or respiratory arrest.

The recall covers different sizes and accessories of Vyaire Medical’s AirLife adult manual resuscitators, spanning some 6.6 million devices. The FDA said that a manufacturing defect—present only in equipment produced in 2017 or before—could result in patients not receiving enough ventilation, or any at all.

In a notice this week, the FDA said it has recorded 37 incidents with the recalled resuscitators, including two injuries and two patient deaths. The defect was corrected in 2017, but older models may still be in use worldwide; these should be checked, then discarded or destroyed, the FDA said.

Vyaire notified customers with an urgent recall letter on January 10, detailing a risk of hypoventilation due to a potentially broken duckbill valve and ring caused by faulty components. The FDA designated the issue a Class I recall, the agency’s most serious, on March 21.

The company previously sold off its respiratory and anesthesia consumables business to SunMed in May 2023, including the AirLife brand, for an undisclosed sum. The FDA said the recalled equipment should not be returned to either manufacturer.

Vyaire was originally launched in 2016 as a spun-out joint venture between BD’s respiratory division and Apax Partners, with the latter taking full control of the company in 2018.