FDA Update on CPAP/BiPAP Recall

Did you know that last June the FDA recalled specific ventilator machines, including Philips Respironics ventilators? They were recalled because of dangerous risks to the health of people who use the machines.  There is a foam in each machine that is used to lessen the sound and vibration. That foam can break down and release chemicals into the air tubes and masks. Those chemicals that users could be breathing are a concern for various health problems. The FDA lists the health risks from breathing or swallowing the chemicals to include headaches, dizziness, allergic irritation, nausea, and even cancer-causing effects. We have also seen injuries from the CPAP including liver damage, kidney injury, pneumonia, worsening asthma, pleural effusions, reactive airway disease (RAD), acute respiratory distress system (ARDA), and chronic obstructive pulmonary disease (COPD).

Recently, the FDA investigated and inspected the Philips Respironics’ manufacturing facility. The investigation is ongoing, but there was an update that included another dangerous machine called the Trilogy Evo ventilators. “The foam was determined to be PE-PUR foam, the same foam used in Philips Respironics devices previously recalled in June 2021.” [1]

If you or someone you know has experienced one or more of the health concerns above, please call or text our office at (336) 333-2244.

[1] U.S. Food & Drug Administration. (2021, November 12). Update: Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication.