Omnipod recall overview:
- Who: Insulet Corporation is recalling approximately 7 million Omnipod Pods.
- Why: A manufacturing issue may cause under-delivery of insulin.
- Where: The recall is active in the United States and internationally.
Insulet is recalling various Omnipod Pod devices due to a manufacturing defect that could result in insufficient insulin delivery.
The recall, announced on May 26, affects specific lots of Omnipod 5, Omnipod DASH and Omnipod Insulin Management System Pods.
These devices are designed for subcutaneous insulin delivery. Insulet identified a potential issue where a small tear in the tubing, or cannula, could lead to insulin leaking outside the Pod, causing under-delivery. This defect was discovered through the company’s ongoing product monitoring.
“If insulin is not delivered properly, users may experience high blood glucose levels due to under-delivery of insulin,” the Omnipod recall states.
Approximately 7 million Pods are included in the recall, about 60% of which are expired, representing roughly 8.5% of global Omnipod Pod production in 2025.
According to the recall notice, 24 serious adverse events have been reported worldwide, including hospitalizations and cases of diabetic ketoacidosis (DKA), with no deaths reported.
This Omnipod recall is an expansion of a previous recall on March 12 that affected only the Omnipod 5.
Consumers can verify online whether their Omnipods are included in the recall
To address the issue, Insulet has strengthened its in-process monitoring and quality controls to detect cannula tears. The company has also ensured a sufficient supply of replacement Pods to avoid any disruption in availability.
Insulet is actively communicating with affected customers, providing instructions on how to identify and discontinue use of impacted Pods, and offering replacements at no cost.
For more information, consumers can visit omnipod.com/check-pods to verify if their Pods are affected and request replacements at no cost. Additionally, consumers can contact Insulet Product Support 24/7 at 1-800-641-2049 or use the live chat feature on the Omnipod website.
International customers are advised to visit the Omnipod website for further assistance.
Insulet reports 24 adverse events worldwide, including hospitalizations and DKA cases, but no deaths have been linked to the Omnipod recalls. The company is not currently facing legal action over the recall, but Top Class Actions follows recalls closely as they sometimes lead to class action lawsuits.
Are you affected by the Insulet recall? Let us know in the comments.
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