Draeger Medical, or Dräger US, recalled more than half a million airway devices because of a manufacturing error that can lead to hypoxia and death, the FDA said May 24.
The Class I recall includes Seattle-Positive Airway Pressure Plus systems and 21 other breathing circuits and anesthesia kits. Draeger alerted customers in mid-April of a risk of glued components separating and interrupting airflow, according to the agency.
More than 570,400 devices are involved in the recall.