The Philips Respironics CPAP recall was announced by the manufacturer on June 14, 2021, after it was discovered that the polyester-based polyurethane (PE-PUR) sound abatement foam used to decrease sound and vibration inside the machines could break down and potentially expose users to toxic foam particles or chemicals off-gassed from the foam. The FDA issued a safety communication on June 30, 2021, warning that the foam may:

• Degrade into particles that could enter the devices’ air pathway and be ingested or inhaled by users, or
• Release chemicals into the devices’ air pathway, which may be inhaled by users. 

“These issues result in serious injury, which can be life-threatening, cause permanent impairment, and require medical intervention to prevent permanent damage,” the FDA warns. At the time of the recall announcement in June 2021, Philips Respironics had already received several complaints regarding the presence of black debris within the air pathway of affected devices and side effects like headache, cough, chest pressure, sinus infection, and upper airway irritation in users. 

Philips recalled the CPAP machines in June 2021, but there is evidence that the company was aware of the issue at least several months and possibly even years before the recall was issued and did nothing to warn consumers or healthcare providers until recently. As one lawsuit states, “these ‘risks’ and certainty of degradation were known before any of the Recalled Breathing Machines were sold, because the properties of polyester polyurethane and likelihood of degradation in this application were known to the industry, were common knowledge to polymer experts and were readily available and known to Defendants before the machines went to market.” The Philips Respironics recall affects the following medical devices manufactured between 2009 and April 26, 2021: