United States: FDA warns on 7 million Omnipod pods in voluntary correction

The FDA is warning users of certain Omnipod insulin pods to check lot numbers and stop using affected pods after Insulet found a manufacturing defect that could cause insulin under-delivery. The alert was updated on June 4, 2026 and applies only to specific lots of Omnipod 5, Omnipod DASH and Omnipod Eros pods, not every Omnipod device.

The problem is a small tear in the cannula tubing above the skin. If that happens, insulin can leak outside the pod instead of being fully delivered. The FDA says people may notice wetness on the skin or adhesive, or smell insulin, but the issue may also go unnoticed. If insulin is not delivered properly, blood sugar can rise and, in severe cases, lead to diabetic ketoacidosis.

Insulet told affected customers to check the lot number on the pod tray lid, the box or the pod itself and discontinue use immediately if a pod is on the affected list. If the pod being worn is from an impacted lot, it should be changed right away. Replacement pods are available at no cost, and the FDA says users should not rely only on pod alerts to spot the problem.

The FDA says about 7 million pods are included in the correction, although roughly 60% have already been used or expired. The agency reported 24 serious injuries and no deaths as of May 20. In a separate SEC filing, Insulet said it expects up to $50 million in costs from the correction in 2026 and does not expect to change its 2026 guidance.

Sources

• FDA Early Alert: Insulet insulin pump issue
• Insulet SEC Form 8-K filed May 26, 2026