US FDA classifies recall of Vyaire Medical’s respiratory devices as most serious

March 21 (Reuters) – The U.S. Food and Drug Administration on Thursday classified the recall of privately held Vyaire Medical’s respiratory support devices as most serious and said their use could cause major injuries or death.

The medical equipment maker recalled certain models of its AirLife Manual Resuscitators, a single patient-use device intended for respiratory support, due to a manufacturing defect.

The use of the recalled devices could result in patients not receiving enough ventilation, which may lead to a drop in blood oxygen levels, the health regulator said.