The FDA has issued on update on Draeger’s May 9 recall of its SafeStar 55 breathing system filter, deeming it a Class 1 recall because of the risk of serious injury or death.

The reason for the recall is the risk of obstructions that may block oxygen flow to patients. The 35,950 affected products were distributed from Aug. 18 to Oct. 12, 2021. The affected product model number is MP01790, and the lot number is LT2103.

The SafeStar 55 is a breathing system filter that is used as part of a ventilator when a patient is under anesthesia or needs breathing assistance. Some defective filters that may be partially obstructed were inadvertently distributed instead of destroyed. 

There has been one complaint and one injury, but no reported deaths, associated with the use of the device, the FDA said.