Philips Respironics and the FDA have announced a Class 1 recall for hundreds of EVO Ventilators and repair kits due to potential health risks.
EVO portable ventilators are also known as “hospital-to-home” ventilators because they are used in institutional, home, and non-emergency transport settings, such as a wheelchair or vehicle.
Philips said that a supplier incorrectly used the toxic foam — known as polyester-based polyurethane (PE-PUR) — in the muffler assembly for certain EVO ventilators.
PE-PUR sound abatement foam is used to reduce sound and vibration in the recalled ventilators. The problem is that PE-PUR foam can disintegrate, and tiny bits of black foam may be inhaled or swallowed by the person using the device. PE-PUR foam may also “off-gas” toxic chemicals that can be inhaled by the person using the device.
The recall only involve Trilogy EVO ventilator model numbers with certain serial numbers — DS2110X11B and KR2110X15B — and repair kits with Part #1135257 and Lots between 210414 and 210524.
They were distributed in the U.S. between April 15, 2021 and May 24, 2021.
Philips previously recalled Trilogy 100 and 200 ventilators due to the same foam risk in June 2021, as well as millions of other ventilators and breathing machines for people with obstructive sleep apnea.
No illnesses or injuries have been linked to the recalled Trilogy EVO ventilator, but the FDA has issued warnings about health risks, including toxic or cancer-causing effects to organs (liver and kidneys), immune reactions, asthma, coughing, pneumonia, and more.