By Katherine Hamilton

Insulet is voluntarily correcting certain insulin pod medical devices due to a manufacturing issue that could result in the pods not delivering enough insulin.

The maker of insulin delivery pods for people with diabetes said its Omnipod 5, Omnipod DASH and Omnipod Insulin Management System pods are all part of the correction.

Some pods from specific lots may have a small tear in the tubing just above the skin. If this occurs, insulin could leak outside the pod and result in under-delivery of insulin to the person wearing the pod.

About 7 million pods are included within the scope of the correction, roughly 60% of which have been consumed or are expired. The pods affected by the correction represent about 8.5% of Insulet's production of Omnipods in 2025.

Shares fell 7.5% to $141.50 in after-hours trading Tuesday. Through the close, the stock was down 46% this year.

People using an affected pod may notice wetness on their skin or pod adhesive, or they could detect the smell of insulin, Insulet said. In some cases, the issue may be difficult to detect and go unnoticed.

If patients aren't receiving enough insulin, it could result in high blood glucose levels and potentially lead to diabetic ketoacidosis.

Globally, there have been 24 reports of serious adverse events. No deaths have been reported.

This correction is separate from an earlier voluntary correction Insulet issued in March on certain Omnipod 5 pods in the U.S. It includes certain pod lots distributed in the U.S. and international markets.

Insulet said it identified the cause of the issue and is strengthening its in-process monitoring and quality controls. It is also communicating with affected customers to help them get replacement pods at no cost.

Insulet has enough supply to replace affected pods and doesn't anticipate any disruption to product availability, it said.

Customers should visit Check Pod to confirm whether their pod lot number is included in the correction, Insulet said.

Write to Katherine Hamilton at katherine.hamilton@wsj.com

(END) Dow Jones Newswires

May 26, 2026 16:41 ET (20:41 GMT)

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