Philips Reaches €288 Million Settlement With US Authorities Over Recalled Respiratory Devices

Dutch healthcare technology company Philips has reached an agreement in principle with the US Department of Justice (DOJ) to resolve criminal and civil investigations linked to its large-scale recall of sleep and respiratory care devices. The proposed settlement involves a payment of €288 million, equivalent to approximately $322 million.

The investigations stem from a recall initiated in 2021, affecting more than 15 million medical devices, including Continuous Positive Airway Pressure (CPAP) machines, bilevel positive airway pressure machines and ventilators. The recall followed concerns that sound-insulating foam used in certain devices could deteriorate, releasing particles that patients might inhale.

According to reports, Philips had identified potential foam degradation issues in 2018, while customer complaints dated back to 2014. However, the US Food and Drug Administration (FDA) became aware of certain issues during an inspection conducted in 2021.

In 2024, the FDA entered into a consent decree with Philips, imposing restrictions on the manufacturing and sale of specified Respironics products in the United States. The agreement also required the company to develop measures for repairing, replacing or refunding affected devices.

The latest DOJ settlement is separate from these regulatory restrictions and remains subject to final documentation. Philips has recorded a provision of €288 million in its third-quarter 2026 financial results, with payment expected during the first quarter of 2027.

Meanwhile, Philips continues working towards meeting FDA requirements before resuming sales of restricted products in the US market. Separate investigations involving certain US state attorneys general remain ongoing.

04-11-2026