FDA Calls Philips Respironics’ Recall Efforts ‘Inadequate’

The US Food and Drug Administration (FDA) issued a notification order to Philips Respironics yesterday requiring the company to notify patients and others of the company’s June 14, 2021, recall of certain ventilators, continuous positive airway pressure (CPAP), and bilevel positive airway pressure (BiPAP) machines. The agency deemed that the company’s notification efforts thus far have been insufficient. As we reported in June, Philips recalled some of those devices because of degradation of the polyester-based polyurethane (PE-PUR) foam used to dampen sound. The PE-PUR foam may degrade into particles that can enter the device’s air pathway and be ingested or inhaled by the user, and off-gas certain chemicals, the company said in June. This can result in serious injury, which can be life-threatening, cause permanent impairment, and/or require medical intervention to prevent permanent injury to users, according to FDA. Now, the agency has determined that a notification order is needed to “eliminate the unreasonable risk of harm posed by the recalled products, because the company’s notification efforts to date have been inadequate.”