On Tuesday, August 3, the U.S. FDA categorized the recent recall of some of Philips’ ventilators as Class 1—the most critical type—stating that their usage could cause injuries or, worse, death. This marks the second Class 1 recall initiated by Philips in 2021.

In June, the Dutch medical equipment company also recalled some of its breathing devices and ventilators, as the foam used to dampen the machines’ sound could degrade and emit small particles that irritate airways.

The FDA said on Tuesday there have been 61 incidents and 25 injuries through the products recalled recently, but no deaths were reported for these issues. The company initiated the second recall also in June and has so far recalled 16,535 devices in the United States. Philips has recalled the V60 and V60 Plus ventilators, as there is a risk of patients receiving reduced oxygen in certain situations which could lead to adverse events.

Read the full article on Reuters.