CPAP Injuries

See the full list of devices recalled on the FDA’s website here.

July 2021

In July 2021, the U.S. Food and Drug Administration (FDA) classified Philips’ voluntary recall as a Class 1 recall. Class 1 recalls are the most serious recalls because it means the devices either contributed to serious injuries or death, or a malfunction has been uncovered that could cause serious harm or death.

August 2021

In August 2021, the FDA announced the findings of their investigation into the Philips recall. The investigation revealed that Philips knew about the PE-PUR foam degradation problem as early as 2016 but did not recall the devices until June 2021.

The investigation also uncovered over 220,000 customer complaints, and more than 100 were about the PE-PUR foam problem. Additionally, at least 14 instances, assessments, and internal test reports from Philips from 2016 to 2021 noted the foam problem. The FDA learned also that Philips failed to conduct sufficient risk analysis or take proper corrective action once it learned about the health risks to consumers.

September 2021

Philips started replacing the PE-PUR foam in the recalled devices with silicone foam.

November 2021

The replacement process halted when the FDA and Philips announced that the replacement silicone foam may still pose a health risk.

March 2022

On March 10, 2022, the FDA ordered Philips to notify all patients and any other relevant parties about the CPAP, BiPAP, and ventilator recalls. The FDA explained the requirement was “necessary to eliminate the unreasonable risk of harm posed by the recalled products because the company’s notification efforts to date have been inadequate.”

The order was issued in accordance with the Federal Food, Drug, and Cosmetic Act, Section 518(a). Under the Act, the FDA has the power to order manufacturers to supply notification if the FDA identifies a device as posing an unreasonable risk and a potential source of considerable harm to the public and the notification is needed to remove such an unreasonable threat of or with no practical way provided by the Federal Food, Drug, and Cosmetic Act to remove such a risk.

The Food and Drug Administration can also order that a notification be sent to all healthcare providers that prescribed such a device, users of the device, others who need to be notified to eliminate the risk of harm to the public. In the March 2022 order, the FDA directed Philips to send these notifications within 45 days.

April 2022

In April 2022, the U.S. Department of Justice subpoenaed Philips’ parent company, Royal Philips, regarding the company’s poor handling of the June 2021 device recall. According to Philips, the subpoena instructed the company to “provide information relating to events leading to the Respironics recall.” Philips CEO Frans van Houten explained that he thinks the DOJ will start an investigation: “They are preparing an investigation and we just have to accept that.”

May 2022

In May 2022, the FDA sent a notice to Philips that they were considering a second order under section 518(a) of the Federal Food, Drug, and Cosmetic Act. The second order would require Philips to submit a plan for the repair, replacement, or refund of the purchase price of the recalled devices that were manufactured before November 2015. Philips was provided the opportunity to request an informational hearing about the proposed order before the FDA makes its final determination.