The concern over pod production grows as Insulet has released another voluntary medical device correction affecting Pods across the Omnipod 5, Omnipod DASH, and Omnipod Eros models manufactured in 2025.

The voluntary correction involves a small tear in the cannula tubing just above the skin, which can cause insulin to leak outside the Pod rather than being delivered into the body. Users with affected Pods may notice wetness on their skin or the smell of insulin, though the issue can go undetected. Insulin under-delivery can cause high blood glucose levels, and in the most serious cases, diabetic ketoacidosis (DKA). Globally, 24 serious adverse events have been reported, including hospitalizations, though no deaths have occurred.

Specific lots of Omnipod 5, DASH, and Eros Pods distributed in the U.S. and select international markets have detected the tear. Insulet is encouraging users to visit omnipod.com/mdc/check-pod-lot to check their pod lot numbers to see if they are affected.

In March 2026, Insulet released another Medical Device Correction for select lots of Omnipod 5. Then in April, the FDA issued a Class I recall for Omnipod 5 after several reported injuries.

Insulet has identified the root cause of the manufacturing issue and has implemented corrective actions to prevent recurrence, along with additional quality controls. The company is proactively reaching out to customers with instructions to check their lot numbers, stop using impacted Pods, and receive free replacements.

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