On June 30, 2021, the Food and Drug Administration (FDA) announced a recall of certain Philips Respironics ventilators, BiPAP, and CPAP machines due to potential health risks. These devices are used to provide breathing assistance.
The polyester-based polyurethane sound abatement foam used to reduce sound and vibration in these affected devices may break down and potentially enter the device’s air pathway. If this occurs, black debris from the foam or certain chemicals released into the device’s air pathway may be inhaled or swallowed by the person using the device.
To date, Philips Respironics has received several complaints about the presence of black debris/particles within the device’s air pathway. Philips Respironics also has received reports of headache, upper airway irritation, cough, chest pressure, and sinus infection, which may be related to this issue, though the cause of the symptoms cannot be definitively linked.
A complete listing of affected devices manufactured between 2009 and April 26, 2021 is available here.
Food and Drug Administration (FDA). Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication. June 30, 2021. Available at: click here. Accessed July 1, 2021.