FDA Offers Update on Philips Respironics’ Recall of BiPAP Machines

The FDA issued an update on Philips Respironics’s Aug. 26 recall of its BiPAP A30, A40, V30 and OmniLab Advanced+ devices, deeming it a Class 1 recall because of the risk of serious injury or death.

The devices, which pump air under varying pressure into the lungs, are for treatment of individuals with obstructive sleep apnea, respiratory insufficiency or respiratory failure.

The recalled devices may contain a plastic contaminated with a non-compatible material, the agency said, adding that if the plastic is in the device motor, it may release volatile organic compounds and may cause the machine to fail suddenly during use.

The 386 affected products were distributed from Aug. 6, 2020 to Sept. 1, 2021. The recall is not associated with a June 2021 recall of the company’s BiPAP machines because of an issue with a foam material, the agency said.