Vyaire has received thirty-seven (37) customer reports relating to product issues, including two deaths and two serious injuries. It has been identified that the affected product issues are due to faulty mold/tooling producing out of specification components. This device failure may result in improper ventilation or no ventilation that may result in hypo-ventilation or hypoxia, and potentially may lead to death. Recall Start Date: January 10, 2024
RecallTracker