According to the FDA, such a recall may cause serious injury or death with continued use.
Insulet announced on March 12 that it initiated a voluntary medical device correction for specific lots of Omnipod 5 insulin pump pods. Omnipod 5 — the world’s first available tubeless, wearable, automated insulin delivery system — is a patch-based pump system designed to proactively correct for glucose highs every five minutes and protect against lows with insulin dosing.
Acton, Massachusetts-based Insulet said it identified a manufacturing issue with certain Omnipod 5 lots through its ongoing product monitoring. Its correction applies to specific identified lots distributed in the U.S.
Insulet said that certain pods from specific lots may have a small tear in the internal tubing that delivers insulin. If this occurs, insulin may leak inside the pod rather than infuse into the body as intended. When the pod fails to deliver insulin properly, users may experience high blood glucose levels due to under-delivery. In severe cases, prolonged and persistent high blood glucose levels can lead to diabetic ketoacidosis (DKA).
At the time of the initial announcement Insulet said it received 18 reports of serious adverse events associated with high blood glucose levels. Those events included hospitalization and DKA. The company reports no deaths related to the issue. It noted that the issue does not affect the continuous glucose monitor (CGM) systems that integrate with Omnipod 5.
Today’s FDA notice says that, as of April 17, 2026, Insulet has reported 476 serious injuries and no deaths associated with this issue. Insulet said this total refers to the number of medical device reports potentially related to device correction rather than the amount of serious adverse events. An April 10, 2026 communication noted 29 confirmed serious adverse events.
More details on the Insulet recall from the FDA
The FDA issued its notice to share that affected product lots and information on the issue changed. Insulet’s recall involves removing certain devices from use or sale. The company instructed customers to not use affected pods.
According to the FDA, Insulet notified all affected customers on April 10 that it expanded the list of affected pods, including the addition of 13 expired lots. It also provided additional details to clarify that the defect may not be detectable by users.
Insulet told customers that a fluid lead inside the pod may lead to a hazard alarm notifying users to remove the device. However, in some cases, users may not receive an alarm or alert, leaving the issue to potentially go unnoticed. This can result in under-delivery of insulin with the potential for prolonged high blood glucose levels.
If this occurs, the user’s blood glucose levels may increase and may not respond as expected to additional insulin delivery. This can result in an automated delivery restriction alert advising users to troubleshoot.
Because this problem may occur without triggering an alarm or alert, users could receive less insulin than required without realizing. As a result, users should not rely only on alarms to become aware of something wrong, Insulet says.
