Insulet Corporation, a company that makes the most prescribed wearable insulin pump in the United States, has voluntarily recalled some of its pod devices March 12 after finding the items may leak, sending some users to the hospital.

The recall includes some batches of Omnipod 5 Pods distributed in the United States, according to the company.

“Insulet has received 18 reports of serious adverse events associated with high blood glucose levels, including hospitalization and [diabetic ketoacidosis],” the company said in a statement.

No deaths have been reported.

After investigating the reports, Insulet found that some of the pods from specific lots may have a small tear in the internal tubing that delivers insulin to the wearer. If that happens, the insulin may leak inside the unit, instead of the dose being fully delivered into the body, according to the company.

If the insulin is not delivered at the proper dose, the users may experience high blood glucose levels because they are not receiving enough insulin.

In the most severe cases, prolonged and persistent high blood glucose levels can lead to diabetic ketoacidosis, a serious medical condition that requires urgent medical treatment, Insulet stated.

The issue giving rise to the recall does not affect the company’s continuous glucose monitoring systems or its continuous glucose monitoring readings.

More than 100,000 people use Insulet’s Omnipod 5 delivery systems in the United States, according to MedTech Dive.

Insulet, based in Acton, Massachusetts, has updated its manufacturing processes after its investigation of the issue to prevent similar problems from happening in the future, the company stated.

The pods covered by the recall make up about 1.5 percent of the annual Omnipod 5 Pod production globally.

To check if your device is included in the recall, visit omnipod.com/check-pods.

An individual holds insulin medicine in Minnetonka, Minn., on Jan. 17, 2020. (Kerem Yucel/AFP via Getty Images)

The recall comes months after a popular glucose monitoring system made by Abbott was recalled after testing showed the units were giving incorrectly low glucose readings.

Abbott recalled about 3 million FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors in the United States in November 2025 due to the issue.

The company received 736 reports of severe adverse events globally and seven deaths potentially associated with the issue, according to Abbott.

An estimated 40.1 million people in the United States have diagnosed or undiagnosed diabetes, according to the Centers for Disease Control and Prevention. Of those, only about 29.1 million have been diagnosed, including 28.8 million adults.

The NIH estimates that 400,000 people with Type 1 diabetes in the U.S. are using insulin pumps.