The Wayne, Penn.-based company began notifying customers of the issue on May 14.
The FDA has labeled the recall as a Class I, the most serious type of recall issued by the federal watchdog, which indicates “there is a reasonable probability that use of these products will cause serious adverse health consequences or death.”
The devices are being recalled due to an issue with the intake oxygen port becoming potentially blocked, which may inhibit air flow and breathing support to the patient, according to the FDA posting.
No reports of death or serious injury have been received related to the issue.
A total of 2,405 units manufactured and distributed between June 2014 and April 2015 are being recalled.
Late last month, Teleflex recalled its Hudson RCI Lifesaver neonate manual resuscitator over the same issue, with 9,333 units affected.