Philips Respironics has expanded its ongoing CPAP machine recall to include additional model numbers after an updated health risk assessment revealed that degraded sound abatement foam can release harmful particles in a wider range of operating conditions than previously identified.
The expanded recall adds 300,000 DreamStation 2 devices manufactured between 2022 and 2024 to the existing recall population. Previous assessments had cleared these newer devices, but long-term testing under high humidity conditions revealed foam degradation issues similar to the original DreamStation units.
The FDA has strengthened its oversight, requiring Philips to submit monthly reports on remediation progress and adverse event reports. Over 5,000 medical complaints have been filed related to the broader CPAP recall, including reports of respiratory issues, headaches, and potential cancer concerns.
Affected patients should contact Philips for a replacement device. In the meantime, the FDA advises patients to consult their healthcare provider before discontinuing CPAP therapy, as untreated sleep apnea also carries significant health risks.
The CPAP recall saga has led to increased regulatory scrutiny of all respiratory device manufacturers and accelerated the development of foam-free CPAP designs. Several competitors have gained market share by marketing devices with alternative sound dampening technologies.
