Medtronic is recalling 322,005 of its MiniMed 600 series insulin pumps after discovering a problem that can cause the user to be given the wrong dose of insulin.
Medtronic said it has received 26,421 complaints and is aware of 2,175 injuries and one death related to the insulin pumps.
The FDA classified it as a Class I recall, the most serious type, meaning use of the devices could cause serious injury or death.
The pumps may have a missing or broken retainer ring, which is supposed to lock the insulin cartridge into place in the pump's reservoir compartment. A missing or broken ring could cause too little or too much insulin to be delivered.
Receiving the wrong dose could cause hypoglycemia or hyperglycemia, which can cause loss of consciousness, seizure or death.
Read the full news release here.