Teleflex Medical is in the process of recalling 9,333 units of its Hudson RCI manual ventilator for emergency resuscitation because “the intake port may be blocked which can cause the bag to fail to fill,” according to the FDA’s recall database.

It’s designated as a Class 1 recall, meaning the agency believes there is a reasonable probability that the use of or exposure to the violative units “will cause serious adverse health consequences or death.”

According to the FDA, Teleflex sent customers a recall notification letter on May 14, 2015, asking them to suspend distribution and quarantine the affected units.