Draeger is the latest to face a recall for ventilator-related technology.
There are more recalls on the horizon for fan-related tech. The FDA said Tuesday that Draeger is facing a Class I recall for a specific lot (LT2103) of the SafeStar 55 breathing system filter because a manual inspection process led to the inadvertent release of some defective filters, including some may be partially obstructed, instead of destroyed. .
The recall affects nearly 36,000 fan filters.
If a ventilator or breathing system filter is clogged, oxygen may not flow properly to the patient. There has been one complaint and one injury associated with the use of this device. No deaths have been reported.
Draeger sent an urgent medical device recall letter on May 16 to customers who may have received filters from the affected lot.
A significant number of ventilators have been recalled in recent years. Late last year, Medtronic experienced a Class I recall for its Puritan Bennett 980 series ventilator.
The Dublin-based company inherited the ventilators when it acquired Covidien for $43 billion. In 2014, before the acquisition, Covidien faced a recall involving a dimming screen and a burning smell from the Puritan Bennet 980.
And just over a year ago, it was reported that some Philips ventilators and sleep apnea devices were undergoing a massive recall. The company is also facing multiple lawsuits over the matter.