Insulet Begins Another Omnipod Recall Over Manufacturing Issue

Insulet announced a Voluntary Medical Device Correction for specific lots of Omnipod 5, Omnipod DASG, and Omnipod insulin management system (Omnipod Eros) Pods due to a manufacturing issue.

The issue, which can result in insulin under-delivery, was identified through ongoing product monitoring. This action is separate from the voluntary correction issued on March 12, 2026 and includes certain Pod lots distributed in the U.S. and affected markets. The company said Pods not included in the lots are safe to use.

Insulet discovered that some Pods from certain 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 this happens, insulin can leak outside of the Pod instead of being fully delivered into the body, possible causing under-delivery of insulin.

Those using an affected Pod might notice wetness on their skin or Pod adhesive and detect the smell of insulin. The company advised that, in some cases, the issue can be difficult to spot and go unnoticed.

About seven million Pods are affected in the scope of this action, about 60% of which have been consumed or are expired. The affected Pods represent about 8.5% of 2025 global Omnipod Pod production. There have been 24 reports of serious adverse events globally related to high blood glucose levels, including hospitalization and diabetic ketoacidosis (DKA). There have been no deaths reported.

The issue doesn’t affect continuous glucose monitoring (CGM) systems or CGM readings.

Insulet identified the cause of this manufacturing issue and implemented corrective actions designed to prevent it from recurring. The company also strengthened its in-process monitoring and quality controls designed to spot cannula tears of this kind.

“Insulet is communicating proactively with affected customers and providing clear instructions to help them identify affected lots, discontinue use of impacted Pods, and obtain replacement Pods at no cost,” the company said in a press release. “The company has sufficient supply available to replace affected Pods and does not anticipate any disruption to product availability.”