Philips Respironics is recalling 386 bilevel positive airway pressure ventilators because the machines could "release chemicals of concern" related to a "non-compatible material" in its plastic, the FDA said Aug. 29.
The recall is not associated with the company's June 2021 recall, in which a foam breakdown issue resulted in pulling more than 3 million ventilators from the market, but some of the recalled BiPAP machines are in the middle of the Venn diagram between both recalls.
As of July 31, there have been 168 deaths and nearly 170,000 complaints reported to the FDA tied to the foam breakdown. There have been no reported injuries or deaths related to the plastic recall.
In June, Philips recalled more than 55,000 ventilators because of a different issue — that recall was related to the devices shutting off without sounding the system's alarm.