In February 2023, the United States Food and Drug Administration (FDA) announced a recall of reworked Philips Respironics machines due to silicone foam deterioration that, if inhaled, could cause serious illness, injury, and even death.
The FDA categorized the updated recall as a Class 1 recall — the most serious classification of FDA recalls — and follows nearly two years of the health care equipment manufacturer coming under various recalls and public scrutiny.
The updated recall applies to more than 13,000 machines and includes Philips Trilogy 100®, Trilogy 200®, and Garbin Plus® models distributed between March and September 2022.
These machines use PE-PUR foam to reduce sound. However, this foam can break down into possibly carcinogenic particles that can enter the device’s air path and be swallowed by the user.
Those who experience debris contamination may also suffer from more serious health complications — including liver, lung, kidney, or head and neck cancer, as well as damage to the kidneys, liver, and lungs.
As of March 10, 2023, no deaths have been reported in connection to the faulty machines. However, more than 80 reports of the machine’s silicone foam deteriorating have been received, with 19 people reporting injuries from the foam.
Years of Philips CPAP Recalls and Concerns
In June 2021, 15 million Philips Respironics machines were recalled after testing showed foam contained within the devices could break down over time and be inhaled.
Millions of people rely on sleep aid machines, known as CPAP and BiPAP machines, to breathe safely during sleep. However, Philips remained negligent when they knew of the dangers in the machines — but did nothing.
After a 3-month inspection, the FDA found executives knew of the foam-degradation problem for well over a year before issuing a voluntary recall. Warnings from inside the company dating back to 2016 included “at least 14 tests” showing the company was “aware of issues and concerns related to the potential foam degradation.”
The FDA continued to put pressure on the manufacturer. In 2022, Jeff Shuren, the FDA’s Director of the Center for Devices and Radiological Health, said the company needed to improve its communication efforts surrounding the recall since many users may not even be aware of the risks.
Additionally, concerns were raised about the replacement silicone foam used in reworked machines — the same foam that is the cause of this year’s recall update.
What to Do If Your CPAP Machine Was Recalled
If you, or someone you love, rely on a Philips Respironics machine that is included in the updated recall, talk with doctors immediately. It is not recommended to stop using the machine until health care providers can determine an alternative.
You may also be eligible to file a Philips CPAP lawsuit if you developed cancer or other organ damage after using a Philips sleep machine.
With over 40 years of experience holding companies accountable for the harm they caused, Sokolove Law is here to help. Let us fight for your family.
Call (800) 995-1212 now to learn more about your legal options during a free case review.