Philips Rebuked By FDA Over Poor Ventilator Recall Efforts

Philips Respironics Insufficient Ventilator Recall Overview:

• Who: The U.S. Food & Drug Administration has issued a notification order to Philips Respironics, censuring it over its insufficient recall efforts of faulty ventilator and airway pressure machines .
• Why: The FDA says the company’s recall has been received by everyone who needs to know, putting them in danger.
• Where: The recall is effective in the United States.

The U.S. Food & Drug Administration (FDA) has issued a warning to Philips Respironics after discovering that the company’s “inadequate” efforts to notify the public about recalled respirators had put people in danger.

On Mar. 10, the FDA sent a legal notification order to Philips Respironics, requiring the company to notify patients and others of its June 14, 2021, recall of certain ventilators, continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) machines. 

The recall came after the company found there was a “risk of substantial harm to the public health” posed by the degradation of the sound abatement foam used in the products. 

The breakdown can cause black debris from the foam to be inhaled or swallowed, causing irreversible harm to lung tissues. 

However, since June, Philips’ efforts to notify the public of the recall have been insufficient, and multiple patients and medical suppliers have claimed they were unaware of the recall nine months later, the FDA said. 

“The FDA has heard the frustration expressed by patients and durable medical equipment suppliers who are unaware of the recall and have received insufficient information on their next steps regarding the recall process,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “Taking this action today enables the FDA to mandate that Philips Respironics improve its communication about the recall and the serious risk posed by the foam used in the recalled products with patients and the public and to ensure that individuals who rely on these essential devices are receiving the important information they need from the company.”  

Philips Must Go Back to Consumers, Medical Providers

The FDA is now ordering Philips Respironics to reach out again to all device users, durable medical equipment  suppliers, distributors, retailers and health care providers who prescribe the products about the recall. The FDA said, based on its research, only 50% of patients who used the product have asked for a refund so far.

In June 2021, Philips North America LLC recalled millions of its BiPAP breathing and CPAP machines that contain toxic foam, leading to dozens of class action lawsuits claiming that the company initially hid the problem from consumers, and is now forcing them to purchase new devices.

Between 3 and 4 million of the BiPAP, CPAP and mechanical ventilator devices were recalled by Philips and its associated manufacturers.

Last month, the recall expanded to 215 of its Trilogy Evo ventilators and 51 repair kits due to the risk of death or serious injury.

In the months since the BiPAP and CPAP machine recall, dozens of class action lawsuits were lodged against the company in multiple states by consumers who say Philips knowingly exposed them and others to dangerous toxins present in sound muffling foam included in their CPAP and BiPAP machines.   

If you used a recalled Philips CPAP machine and were diagnosed with cancer or a lung injury you may qualify to join a free CPAP recall class action lawsuit investigation. Click here for more information.

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