Insulet Corporation of Acton, Massachusetts, has recalled specific lots of Omnipod 5 insulin pump pods after identifying a manufacturing defect that can cause a small tear in the internal insulin delivery tubing — silently reducing or stopping insulin delivery while the pod continues to appear functional. The FDA has classified it as its most serious type, indicating continued use may cause serious injury or death. As of April 17, 2026, Insulet has reported 476 serious injuries and no deaths.
What’s Being Recalled?
The recall covers specific lots of Omnipod 5 Pods used with the Omnipod 5 Automated Insulin Delivery System. All other Omnipod 5 pods and all other Omnipod products remain safe to use — only pods from the identified lots are affected. Users can check whether their pods are included at omnipod.com/check-pods. The lot number is printed on the pod tray lid, box, and pod itself. Replacement pods are available at no cost.
Why Was This Product Recalled?
Insulet identified that certain pods from specific lots may have a small tear in the internal tubing that delivers insulin. When this occurs, insulin leaks inside the pod rather than entering the body. Critically, the pod may continue to appear functional — users may not realize their insulin delivery has been interrupted. Prolonged under-delivery can cause high blood glucose levels, and in severe cases can lead to diabetic ketoacidosis — a life-threatening medical emergency requiring immediate treatment. DKA warning signs include nausea, vomiting, abdominal pain, confusion, rapid breathing, and fruity-smelling breath. The risk of under-delivery increases if a user wears more than one affected pod in succession. The injury count has risen sharply — from 18 reports at the initial March announcement to 476 as of April 17.
What Should You Do?
Check your lot numbers immediately at omnipod.com/check-pods to determine whether your pods are affected. Do not use pods from affected lots. If you are currently wearing a pod from an affected lot, change it immediately to resume proper insulin delivery. Monitor blood glucose closely and watch for symptoms of high blood sugar or DKA. Contact Insulet Product Support at 1-800-641-2049, available 24 hours a day, 7 days a week, for replacement pods and guidance.
