An estimated 7 million Omnipod insulin pods could have manufacturing errors leading to under-delivery of the medicine, the manufacturer said in an alert.
WASHINGTON — An estimated 7 million Omnipod insulin pods are under a voluntary Medical Device Correction due to a manufacturing error that can make the pods under-deliver insulin.
The alert, issued by Insulet Corporation, Inc. and the FDA on May 26, comes after 24 reports of “serious adverse events” including hospitalization caused by high blood glucose levels due to the under-delivery. No deaths have been reported.
The correction said a manufacturing error caused a small tear in the tubing between the skin and the pod, which can cause insulin to leak instead of be delivered into the body, potentially leading to under-delivery of the medication.
Omnipod 5, Omnipod DASH, and Omnipod Insulin Management System (Omnipod Eros) Pods are impacted by the correction alert. The alert is not restricted to the United States as these products were distributed globally. This correction does not impact continuous glucose monitoring systems or CGM readings.
These pods were issued to at least 22 countries, according to the product’s website.
Insulet said an estimated 60% of impacted pods have either expired or been used. The correction impacts roughly 8.5% of the company’s global production from 2025.
Users may smell insulin or notice wetness or adhesive on their skin after the pod distributes product. The alert said users may not notice the issue because it may be difficult to detect.
Insulet is reaching out to users with these products to help them identify the problematic pods. Anyone with said pods is urged to stop using them and get replacement, working pods at no extra cost.
Each country has a different product and lot code and where to find it. Search your pod lot code here.