Millions of certain Omnipod insulin pods recalled over leaking defect

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Published  May 26, 2026 9:14 PM EDT
FOX Local

FILE - Omnipod Dash on a woman's arm. (Omnipod) 

The Brief

    • Insulet Corporation has issued a voluntary recall affecting approximately 7 million Omnipod insulin pods due to a manufacturing defect.
    • The product defect involves a small tear in the device's tubing that can cause insulin to leak outside the pod instead of entering the body.
    • This resulting under-delivery of insulin can cause dangerously high blood glucose levels or life-threatening diabetic ketoacidosis.

Millions of Omnipod insulin pods have been recalled due to a possible leaking defect, according to the U.S. Food and Drug Administration.

Dig deeper:

Specific lots of Omnipod 5, Omnipod DASH and Omnipod Insulin Management System (Omnipod Eros) pods could have a small tear in the tubing just above the skin. This can lead to a leakage outside the body, preventing the full amount of insulin from being delivered.

By the numbers:

Approximately 7 million Omnipods have been included in this recall. 

"Globally, there have been 24 reports of serious adverse events associated with high blood glucose levels, including hospitalization and DKA (diabetic ketoacidosis)," the FDA alert said. 

As of this report, there have been no deaths related to this recall. 

What you can do:

Insulet Corporation, Inc., the manufacturers of the Omnipods, is contacting customers impacted by this recall. 

Consumers who have a defective pod should stop using them immediately. Insulet will replace all defective Pods included in this recall for free. 

To see if a pod was included in this recall, locate the lot number on the pod tray lid or on the pod itself. Once the lot number is located, customers can check to see if their pod was included in the recall by entering the number here.

Customers who have further questions can contact Insulet Product Support at 1-800-641-2049 or use the live agent chat at www.omnipod.com/current-podders.

The Source: Information for this article was taken from the U.S. FDA website and the Omnipod’s website. This story was reported from San Jose.

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