FDA Issues Early Alert on Insulet Omnipod Insulin Pump Under-Delivery Risk

The U.S. Food and Drug Administration (FDA) has issued an Early Alert regarding Insulet's recommendation for customers to remove certain Omnipod Pods due to a potential insulin under-delivery issue. This alert impacts the Omnipod 5 Automated Insulin Delivery System, Omnipod DASH Insulin Management System, and Omnipod Insulin Management System (Omnipod Eros).

Insulet identified that some Pods from specific lots may have a small tear in the tubing (cannula) just above the skin. This defect can cause insulin to leak outside the Pod instead of being fully delivered into the body, potentially leading to under-delivery. Users might notice wetness on their skin or Pod adhesive, or detect the smell of insulin, though detection can be difficult.

This new issue is separate from a previous Insulet communication concerning Omnipod 5 Pods on March 12, 2026. U.S. customers experiencing adverse reactions, quality problems, or having questions about this issue should contact Insulet directly at 1-800-641-2049 or via their website at https://www.omnipod.com/current-podders.