If you’ve heard about the 2026 Omnipod® recall, you may be wondering whether your insulin pump is affected and what it could mean for your health. Reports of device malfunctions have raised concerns among patients who rely on the Omnipod system to manage diabetes, and some individuals have filed lawsuits alleging that defects caused serious injuries.
If you or a loved one used an Omnipod 5 insulin pump and was then diagnosed with ketoacidosis or severe hyperglycemia, or experienced hospitalization or ER visits, you may qualify for the Omnipod insulin pump lawsuit.
What is the OmniPod 5?
The Omnipod® 5 is a wearable, automated insulin delivery device that can provide injection-free insulin for up to three days.
The device is designed to help correct blood glucose levels and provide users with more freedom in their daily lives. It works by predicting your future glucose levels up to 60 minutes ahead by using sensors and health trends. It will then adjust insulin delivery using a customizable target glucose range and will automatically increase, decrease, or pause insulin delivery every five minutes.
What caused the Omnipod recall in 2026?
The Omnipod recall of 2026 was initiated after ongoing product monitoring identified a manufacturing issue affecting certain Omnipod Pods. According to the FDA, the recall involves Pods from specific lots that may have been damaged during the manufacturing process.
Insulet, the manufacturer of Omnipod, determined that some affected Pods may have a small tear in the tubing (cannula) located just above the skin, between the Pod and the point where the cannula enters the body. This damage may allow insulin to leak outside the device instead of being delivered into the body as intended.
People using an affected Pod may notice wetness on their skin or the Pod’s adhesive, or they may notice the smell of insulin leaking from the device. However, the leak is not always noticeable. This means some people may not realize their Pod is malfunctioning until they experience symptoms caused by insufficient insulin delivery.
What are the risks of insufficient insulin delivery?
Insufficient insulin delivery can cause serious and sometimes lethal consequences for people who rely on insulin injections to manage their diabetes. These complications include ketoacidosis and severe hyperglycemia.
Diabetic ketoacidosis
Diabetic ketoacidosis (DKA) is a serious and often life-threatening complication of diabetes that occurs when the body doesn’t receive enough insulin. DKA is most common in people with type 1 diabetes, but people with type 2 diabetes can also develop it.
DKA develops when your body doesn’t have enough insulin to move glucose from your bloodstream into your cells for energy. As a result, your liver begins breaking down fat for fuel and producing acids called ketones. When ketones build up too quickly, they can reach dangerous levels in the bloodstream.
Hyperglycemia
Hyperglycemia, or high blood sugar, occurs when there isn’t enough insulin to move glucose from the bloodstream into the body’s cells. For people with diabetes, hyperglycemia can result from several factors, including illness, diet, physical activity, missed insulin doses, or problems with insulin delivery.
Prompt treatment is important because untreated hyperglycemia can become severe and lead to serious complications, including DKA, diabetic coma, and other medical emergencies.
Even when it is not immediately life-threatening, prolonged hyperglycemia can damage the eyes, kidneys, nerves, heart, and blood vessels over time.
How do I know if my device is part of the Omnipod recall?
Omnipod manufacturer, Insulet Corporation, encourages individuals who suspect their device comes from an affected lot to visit Check Pod Lot to confirm whether their Pod is included in the Omnipod recall.
If your device is included in the affected lots, you can request replacement Pods at no cost. If your potentially defective Pod is currently in use, you should stop using it and replace it with a Pod from an unaffected lot immediately.
What is the Omnipod insulin pump lawsuit?
On May 26, 2026, the U.S. Food and Drug Administration (FDA) announced a recall of approximately 7 million Omnipod insulin pump Pods after a manufacturing issue was identified. About 60% of affected Pods had already been used or had expired by the time the recall was issued. The recalled devices represent roughly 8.5% of Omnipod’s global Pod production in 2025.
According to the FDA, the recalled Pods have been linked to 24 reports of serious adverse events worldwide, including hospitalizations and DKA resulting from prolonged high blood glucose levels (hyperglycemia). No deaths have been reported at this time.
The Omnipod insulin pump lawsuit alleges defective Pods can cause prolonged hyperglycemia, which may lead to diabetic ketoacidosis.
Joining the insulin pump lawsuit
If you or a loved one used an OmniPod 5 insulin pump and were later diagnosed with ketoacidosis, severe hyperglycemia, or experienced hospitalization, frequent ER visits, or complications due to insulin delivery failure, you may have a case.
Fill out the form below or contact us today for a free case evaluation.
OmniPod® is a registered trademark of Insulet Company. Their name is used here only for the purpose of identifying the products in question. Woods & Woods, LLC is not affiliated with, sponsored by, or associated with the FDA or Insulet Company. Never stop taking a medication without first consulting your doctor.
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