Institute of Good Manufacturing Practices India®

(An Autonomous Body Recognized by Ministry of Commerce & Industry, Government of India)

Vyaire Medical recalls Airlife resuscitators over defect connected to 2 death reports

In January, Vyaire advised customers and distributors to discard Airlife manual resuscitators made in 2017 or earlier or lacking a manufacturing date. Though the fault only affects pre-2017 devices, the FDA warned that those distributed before the defect correction might still be in use.

The defect in these single-patient-use resuscitators, intended for respiratory support, can lead to insufficient ventilation, risking inadequate oxygen exchange and low blood oxygen levels, posing serious health risks. Consequently, the FDA classified Vyaire's action as a Class I recall due to potential severe injury or death.

The FDA had received 37 incident reports related to the recalled Airlife resuscitators, including two injuries and two fatalities.

Sunmed, now Airlife, acquired Vyaire’s respiratory and anaesthesia consumables business as part of its expansion strategy. Supported by Dempsey Ventures and Frazier Healthcare Partners, the U.S.-based medtech company acquired Salter Labs, Westmed, Vyaire’s consumables business, and Avanos Medical’s respiratory health operation.