Philips Respironics recalled 73,000 ventilators because of a risk of dirt and dust clogging the device, which can block the air path and lead to serious injury or death.
Environmental debris in the ventilators could manipulate the air pressure, volume or flow and result in hypoventilation or a buildup of carbon dioxide and other gas pressure, according to the FDA.
Philips has received 542 reports about the issue, and no injuries or deaths have been reported as of Aug. 14.
The affected products are some lots of the Trilogy Evo, Evo O2, EV300, and Evo Universal ventilators, which were distributed between March 2019 and March 2023.