Continuous Positive Airway Pressure (CPAP) machines are widely prescribed medical devices used to treat sleep apnea, a condition where breathing repeatedly stops and starts during sleep. This therapy involves delivering pressurized air to keep the user’s airway open, managing a potentially life-threatening respiratory disorder. A massive, global recall event involving a leading manufacturer’s sleep and respiratory devices was initiated in June 2021, impacting millions of machines worldwide. This action was taken due to potential health risks stemming from a component within these devices.
Identifying the Affected Devices
The recall primarily involved numerous models of CPAP, BiPAP (Bilevel Positive Airway Pressure), and mechanical ventilator devices manufactured between 2009 and April 26, 2021. The affected products include a broad range of the manufacturer’s popular sleep therapy platforms, such as the entire DreamStation line of CPAP and BiPAP machines, including the DreamStation Go and DreamStation ASV models. Other product families were also included, specifically the SystemOne series, which encompasses the Q-Series and the SystemOne ASV4. Device owners should locate the serial number on their machine to verify if it falls within the recalled population, as this is the most definitive way to confirm involvement.
The Source of the Safety Risk
The reason for the recall centers on a specific material used for sound dampening within the devices: polyester-based polyurethane (PE-PUR) foam. This foam was incorporated to reduce the noise and vibration produced by the machine during operation. Under certain conditions, such as high heat or humidity, or when exposed to unapproved cleaning methods like ozone or UV light, the foam can degrade. When the PE-PUR foam breaks down, it can produce black debris or particles that may enter the device’s air pathway, where they could be inhaled or ingested by the user. Exposure to these particles and chemical compounds has been linked to potential health issues, including irritation of the skin, eyes, and respiratory tract, headache, and toxic effects.
Immediate Actions for Device Owners
Individuals who discover they own a device involved in the recall should take immediate steps to manage their health and begin the remediation process. For users of non-life-supporting devices, such as most CPAP and BiPAP machines, the manufacturer and regulatory bodies advised discontinuing use. However, patients should first consult with their physician or healthcare provider before stopping therapy. Stopping sleep apnea treatment can lead to serious health consequences, so a doctor can determine the best course of action, which may include using an alternative device or therapy. Device owners must register their machine on the manufacturer’s dedicated website using the device’s serial number. Furthermore, users must immediately stop using any cleaning methods involving ozone or ultraviolet light.
Status of the Repair and Replacement Program
The recall was designated as a Class I recall by the U.S. Food and Drug Administration (FDA), the most serious classification, indicating potential for serious injury or death. To address the issue, the manufacturer initiated a remediation program to either repair the affected devices or replace them with a new or refurbished machine. The repair process involves replacing the problematic PE-PUR foam component with a new, safer silicone-based material. The sheer volume of affected devices created significant logistical challenges and long wait times for users. As of early 2024, the manufacturer had remediated a substantial percentage of the recalled devices. The FDA entered into a consent decree with the manufacturer in April 2024, restricting the production and sale of new devices in the United States until certain safety requirements are met.