Insulet is warning U.S. Omnipod 5 users about a manufacturing issue affecting a small number of pod lots that could prevent insulin from properly reaching the body. The company issued a medical device correction, now listed in the FDA recall database, impacting about 1.5% of its annual global pod production.

The problem comes from a small tear in the internal pod tubing that can cause insulin to leak inside the pod rather than infuse under the skin. This may lead to under-delivery of insulin and dangerous hyperglycemia, a serious risk for people relying on continuous insulin therapy. Insulet reports 18 serious adverse events linked to the issue, including hospitalizations and cases of diabetic ketoacidosis (DKA), with no deaths reported.

Insulet says manufacturing and shipments will continue without disruption, and new patient starts remain unaffected. The notice comes as broader reliability concerns surface across diabetes devices, including recent recall activity involving Unomedical infusion sets.

Users are encouraged to check their pod lot numbers using Insulet’s online checker or contact support directly. Anyone with affected pods should switch immediately and monitor for unexplained high blood sugars or symptoms of DKA.

Disclaimer: Diabetech content is not medical advice—it’s for educational purposes only. Always consult with a physician before making changes to your healthcare.