Nearly 30 Serious Injuries Tied to Recalled Insulin Pods, FDA Says

— Small internal tears in Omnipod 5 insulin pump pods could lead to underdosing May 1, 2026 • 2 min read Omnipod 5 insulin delivery pods subject to a class I recall have been linked to nearly 30 serious injuries, the FDA said on Thursday. The agency reiterated that patients should not use pods from 49 affected lots that may have a small tear in the internal tubing, which may cause insulin to leak inside the pod, leading to under-delivery of medication. When the voluntary recall was initiated on March 12, manufacturer Insulet had received 18 reports of serious adverse events tied to hyperglycemia, including hospitalization and diabetic ketoacidosis (DKA). As of April 17, Insulet has reported 29 serious injuries and no deaths associated with this issue, the FDA said. (An agency communication on Wednesday erroneously reported the number of serious injuries; that number has since been corrected.) "If insulin is not delivered properly, users may experience high blood glucose levels due to under-delivery of insulin," the FDA said. "In the most severe cases, prolonged and persistent high blood glucose levels can lead to DKA, a serious medical condition that requires prompt medical treatment and can be life-threatening if not