ACTON, Mass. — Insulet Corp. has initiated a voluntary medical device correction for specific lots of Omnipod 5, Omnipod DASH and Omnipod Insulin Management System pods because of a manufacturing issue that could result in insulin under-delivery.
The Acton-based medical device company said the issue was identified through ongoing product monitoring and affects certain pod lots distributed in the U.S. and some international markets. Insulet said pods not included in the affected lots remain safe to use.
The company said the action is separate from a voluntary medical device correction issued March 12, 2026, that affected certain Omnipod 5 pods in the U.S.
Insulet said some pods from specific lots may have a small tear in the cannula just above the skin, between the pod and the point where the cannula enters the body. If that occurs, insulin may leak outside the pod instead of being fully delivered into the body, potentially leading to under-delivery.
Users of affected pods may notice wetness on their skin or pod adhesive or detect the smell of insulin. In some cases, however, the problem may be difficult to detect and go unnoticed.
If insulin is not delivered properly, users may experience high blood glucose levels. In severe cases, prolonged and persistent high blood glucose can lead to diabetic ketoacidosis, a serious condition that requires prompt medical treatment and can be life-threatening if untreated.
Insulet said about 7 million pods are included in the correction, though about 60% have already been used or are expired. The affected pods represent about 8.5% of the company’s 2025 global Omnipod pod production.
Globally, Insulet said there have been 24 reports of serious adverse events associated with high blood glucose levels, including hospitalization and diabetic ketoacidosis. No deaths have been reported.
The issue does not affect continuous glucose monitoring systems or CGM readings, according to the company.
Insulet said it has identified the cause of the manufacturing issue and implemented corrective actions designed to prevent it from recurring. The company said it has also strengthened in-process monitoring and quality controls intended to detect cannula tears.
Insulet said it is contacting affected customers with instructions on how to identify affected lots, stop using impacted pods and obtain replacement pods at no cost. The company said it has enough supply to replace affected pods and does not expect any disruption to product availability.
The U.S. Food and Drug Administration and other relevant regulatory authorities have been notified of the correction.
Customers are being instructed to check whether their pod lot number is included in the correction and request replacement pods at no cost. If a pod from an affected lot is currently in use, customers should discontinue use and replace it with a pod from an unaffected lot.
U.S. customers with questions may contact Insulet Product Support at 1-800-641-2049.
