Certain Philips ventilators that were recalled last year may lead to injuries or death, according to a new classification of the recall by the U.S. FDA.

The Dutch medical equipment company initiated the recall of 215 Trilogy Evo ventilators and 51 repair kits in the United States in December due to potential health risks from a type of foam used in the devices.

So far, there have been no reported injuries or deaths from the products, which were distributed in the United States and Korea, the FDA said.

“We have already reached the majority of affected customers and we will correct this issue via a repair (replacement of the foam) on site in the coming months” a company spokesperson said in an emailed statement to Reuters.

Read the full article at Reuters.