On August 29, 2022, the FDA announced that Philips Respironics recalled certain bi-level positive airway pressure (BiPAP) machines that contain contaminated plastic. If the plastic reaches the device motor, it may emit dangerous volatile organic compounds. Also, the plastic can stop the machine to suddenly stop working. The agency did specify that this is a separate recall from the one in June 2021 for toxic PE-PUR foam in Philips CPAP and BiPAP machines.
Philips Previously Recalled Machines in 2021
Philips Respironics manufactures CPAP and BiPAP machines to treat patients with sleep apnea. Patients with this sleep disorder may randomly stop breathing while sleeping. Therefore, they turn to positive airway therapy ventilators to produce pressurized air that supports a person’s airways during sleep. CPAP machines have one pressure setting, while BiPAP machines have two: one for inhalation and another for exhalation.
However, in 2021 Philips issued a massive recall of millions of its CPAP and BiPAP machines. The company discovered that the sound abatement PE-PUR foam can degrade to release toxic particles and carcinogenic gasses. Since Philips did not install a filter in these ventilators, users were breathing in these hazardous particles nightly.
New Recall Affects 386 BiPAP Machines in the United States
This most recent Philips recall only involves BiPAP ventilators. Although this recall does not pertain to the one last year, it does apply to machines recalled in 2021. According to the FDA, Philips distributed 386 affected BiPAP ventilators in the U.S. between August 6, 2020, and September 1, 2021. On August 26, Philips sent out an Urgent Medical Device Recall letter to inform customers about the affected machines. The recalled models include:
- A-Series BiPAP A30 (Ventilator)
- A-Series BiPAP A40 (Ventilator)
- A-Series BiPAP V30 (Auto Ventilator)
- OmniLab Advanced+
The June 2021 recall included the A-Series BiPAP A30 and A-Series BiPAP A40 (Ventilator). Individuals who already replaced or corrected these specific models through the June 2021 recall already had the plastic components replaced as well. Some of the affected models are only for clinical environments, but others may be used at home or in clinical settings.
Dangers of Inhaling Volatile Organic Compounds
BiPAP machines with plastic contaminated with a non-compatible material can expose users to volatile organic compounds. Inhaling VOCs may cause:
- Irritation in the eyes, nose, respiratory tract (airway), and skin
- Hypersensitivity reaction, such as an allergic reaction or another immune system reaction
- Nausea or vomiting
- Toxic and cancer-causing effects
Also, if the BiPAP machine suddenly turns off during use, the user may suffer injury or death.