Dive Brief:

• Vyaire Medical is recalling more than 6 million Airlife manual resuscitators because of a manufacturing defect linked to reports of two injuries and two deaths, the Food and Drug Administration said Thursday.
• The recall, which Vyaire began in December, covers respiratory support devices made in 2017 or earlier that can fail to provide enough ventilation. The manufacturing defect responsible for the fault was corrected in 2017.
• BD created Vyaire as a joint venture in 2016 and sold its stake in 2018. Vyaire sold the Airlife portfolio and the rest of its respiratory and anesthesia consumables business to Sunmed in 2023.

Dive Insight:

Vyaire wrote to customers and distributors in January to ask anyone with Airlife manual resuscitators that were made in 2017 or earlier, or lack a manufacturing date, to discard or destroy the products. The fault only affects devices made in 2017 or earlier, but the FDA said resuscitators distributed before the manufacturing defect was corrected may still be in use.

The defect can cause the single patient use resuscitators, which are intended for respiratory support, to fail to provide enough ventilation. Some patients may not receive any ventilation. The FDA said patients with too little ventilation may be unable to properly exchange oxygen and carbon dioxide or experience a drop in blood oxygen.

Because those conditions can lead to serious injury or death, the FDA categorized Vyaire’s action as a Class I recall. The FDA had received reports of 37 incidents related to the recalled Airlife resuscitators at the time of its notice, including the reports of two injuries and two deaths. 

Sunmed, which has now rebranded as Airlife, acquired Vyaire’s respiratory and anesthesia consumables business as part of its growth strategy. Supported first by Dempsey Ventures and by Frazier Healthcare Partners since 2021, the privately owned U.S. medtech company has acquired Salter Labs, Westmed, Vyaire’s consumables business and Avanos Medical’s respiratory health operation.