Insulet recalls Omnipod insulin pump pods after insulin delivery flaw

Insulet has launched a voluntary correction of certain Omnipod insulin pump pods after finding a manufacturing defect that can cause patients to receive too little insulin, a failure that can quickly become dangerous for people who depend on precise daily dosing. The problem involves a small tear in the cannula tubing just above the skin, allowing insulin to leak instead of being fully delivered into the body.

The correction covers specific lots of Omnipod 5, Omnipod DASH and Omnipod Insulin Management System, also known as Omnipod Eros, pods distributed in the United States and in affected international markets. The U.S. Food and Drug Administration said about 7 million pods are included, equal to roughly 8.5% of Insulet’s 2025 global Omnipod pod production. Insulet said about 60% of the affected pods have already been used or expired.

For patients, the risk is immediate and practical. Under-delivery can push blood sugar dangerously high and, in severe cases, lead to diabetic ketoacidosis, a life-threatening condition requiring prompt medical treatment. The defect may sometimes trigger a hazard alarm or an Automated Delivery Restriction alert, but Insulet warned it can also happen without any warning. Reuters reported that some users may notice wetness or the smell of insulin, yet the issue can go unnoticed, which makes the failure especially concerning for insulin-dependent users trying to manage dosing hour by hour.

The FDA said Insulet announced the correction on May 26, 2026. The agency also said the current action is separate from a March 12, 2026 correction involving certain Omnipod 5 pods in the U.S., even though both cases involved cannula handling at Insulet’s Massachusetts facility. Insulet later expanded the March correction on April 10 to include expired pods and said that earlier issue was limited to identified U.S. lots. The FDA identified the March Omnipod 5 recall as its most serious type, meaning continued use could cause serious injury or death.

Insulet has reported 24 serious adverse events tied to the current correction, including hospitalizations and diabetic ketoacidosis, with no deaths. In March, the company had reported 18 serious adverse events and no deaths, and later said the earlier correction had reached 29 serious adverse events after its April update. Insulet said it has already implemented manufacturing-process and quality-control changes after investigating the earlier problem.

The company said it does not expect supply disruptions and sees up to $50 million in related costs this year. That financial hit is secondary to whether Insulet moves quickly, clearly and at scale to replace affected pods without interrupting treatment for the patients who rely on Omnipod’s tubeless insulin pump platform every day.