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The Food and Drug Administration (FDA) issued a statement saying at least 561 deaths reported between April 2021 and September 2023 may be linked to Philips sleep apnea devices, typically referred to as “CPAP” (continuous positive airway pressure) machines. About 5 million of the devices were first recalled in 2021. The CPAP machines contain materials that have been found to deteriorate and cause serious health concerns. At issue is the polyester-based polyurethane (PE-PUR) foam components that can break down, sending foreign particles into the users’ airways or esophagus. The potential risks from inhaling or swallowing pieces of PE-PUR foam include: irritation to the skin, eyes, nose, and respiratory tract; inflammatory response; headache; dizziness; allergic reaction; nausea or vomiting; asthma; and cancer-causing effects to organs.
What’s happening now: Philips no longer sells the CPAP machines in the US, and a class action settlement of $445 million is on the table. A list of the recalled devices can be found on the FDA statement, and the agency encourages providers to report any observed or suspected adverse events related to the machines on a MedWatch form.