The Philips Respironics Recall of Ventilators and Positive Airway Pressure Machines—Breakdowns in Medical Device Surveillance

In June 2021, Philips Respironics (Philips) initiated one of the largest medical device recalls in history, affecting more than 10 million devices in the United States and 15 million devices worldwide.¹ Philips recalled 14 models of ventilators and positive airway pressure machines (both bilevel positive airway pressure [BPAP] and continuous positive airway pressure [CPAP] machines) using polyester-based polyurethane (PE-PUR) sound abatement foam owing to concerns that foam degradation could harm patients through inhalation of toxic particles and emissions. The US Food and Drug Administration (FDA) categorized this recall as Class I (the most severe designation), indicating reasonable probability that device use could cause serious adverse health consequences or death.