Philips Halts Sales of Recalled Sleep Apnea Machines in the US
Following the discovery that its sleep apnea machines were releasing foam particles into users’ airways, Philips has announced it will cease sales of CPAP and BiPAP devices in the US until it meets the FDA’s requirements. The decision comes after the company’s 2021 recall of the machines due to potential health risks associated with the polyester-based polyurethane foam used to reduce noise and vibration.
According to Philips, the foam has the potential to break down, posing a risk of inhalation or ingestion for users, possibly resulting in injury. The company has entered a consent decree with the Department of Justice and FDA, though details of the agreement are pending court approval.
While continuing to provide service for sleep and respiratory devices in the US, Philips will still sell machines outside of the country. The Netherlands-based company has allocated €363 million (about $394 million) to meet the FDA’s requirements.
