The U.S. Food and Drug Administration (FDA) is alerting patients, caregivers, and healthcare providers that Philips Respironics (Philips) recalled certain bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines that may contain a plastic contaminated with a non-compatible material. If that plastic is in the device motor, it may release certain chemicals of concern called volatile organic compounds (VOCs). The plastic may also cause the machine to fail and stop working suddenly during use.

This recall is not associated with the PE-PUR foam issue impacting certain BiPAP machines recalled in June 2021, described in the Update: Certain Philips Respironics Ventilators, BiPAP Machines, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication. However, this new recall does apply to some of the devices recalled in June 2021.

Philips distributed 386 affected BiPAP machines in the U.S. between Aug. 6, 2020, and Sept. 1, 2021. On Aug. 26, 2022, Philips sent affected customers, including Durable Medical Equipment (DME) suppliers, an Urgent Medical Device Recall letter. The models, some of which are intended for use only in clinical environments, are listed below; however, only machines with the serial numbers identified in the company’s Urgent Medical Device Recall letter are affected by this recall.

  • A-Series BiPAP A30 (Ventilator)
  • A-Series BiPAP A40 (Ventilator)
  • A-Series BiPAP V30 (Auto Ventilator)
  • OmniLab Advanced+

Read the FDA Alert