Omnipod Recall Impacts Another 7 Million Defective Pods That May Cause DKA, Hospitalization

Recall involves Omnipod 5 insulin delivery pods that may leak insulin due to internal tubing defects, potentially causing dangerous blood sugar spikes that can lead to coma or death.

Federal regulators announced another Omnipod recall this month, which expands a prior warnings issued earlier this year to include another 7 million insulin delivery pods, following increased reports that defects may prevent the devices from delivering insulin properly.

The U.S. Food and Drug Administration (FDA) announced the Omnipod recall update on May 26, indicating that Insulet Corporation is removing additional Omnipod 5 Pods from use after identifying problems linked to insulin under-delivery.

Omnipod Failure Risks

Omnipod 5 systems are wearable insulin delivery devices used by individuals with Type 1 and Type 2 diabetes. The system uses disposable pods that continuously deliver insulin through a small cannula inserted beneath the skin, helping users manage blood glucose levels without multiple daily injections.

When functioning properly, Omnipod 5 systems automatically adjust insulin delivery based on continuous glucose monitor (CGM) readings. However, if insulin delivery is interrupted or reduced without the user realizing it, blood glucose levels may rise rapidly, potentially triggering severe metabolic emergencies.

According to the FDA, certain Omnipod 5 Pods may contain a manufacturing defect involving small tears in the internal tubing or soft cannula responsible for insulin delivery. If the tubing becomes damaged, insulin may leak inside the pod instead of being delivered into the body as intended, causing dangerous spikes in blood sugar levels.

Federal regulators warn that prolonged insulin under-delivery may lead to diabetic ketoacidosis (DKA), a serious medical emergency that can result in hospitalization, coma or death if not promptly treated.

Omnipod Recall Injuries

The current Omnipod recall significantly expands a March 2026 medical device correction involving certain Omnipod 5 Pods distributed nationwide. At the time of the original recall, Insulet reported 18 serious adverse events involving high blood glucose levels, hospitalizations and diabetic ketoacidosis.

However, that number jumped dramatically in the following weeks, with the FDA eventually announcing there were at least 476 reports of serious injuries linked to the Omnipod 5 pods.

Insulet later clarified that the FDA’s announcement of 476 serious injury reports involved potential, rather than confirmed cases. Federal regulators now indicate the number of confirmed injuries has reached 24, and the recall impacts approximately 7 million pods distributed throughout the United States.

Potential complications associated with Omnipod 5 pod malfunctions may include:

• Severe hyperglycemia: If the pod delivers too little insulin, blood sugar levels may increase rapidly, sometimes before users realize the device is malfunctioning. Regulators caution that interruptions in insulin delivery may not always be immediately noticeable, potentially delaying treatment.
• Diabetic ketoacidosis (DKA): DKA is a life-threatening emergency that develops when the body lacks sufficient insulin to process glucose, forcing it to break down fat and produce dangerous ketone levels. Symptoms may include nausea, vomiting, abdominal pain, confusion, rapid breathing and fruity-smelling breath. Without immediate treatment, DKA can lead to dehydration, organ failure or death.
• Hyperosmolar hyperglycemic state (HHS): HHS is another severe diabetes-related emergency caused by extremely elevated blood sugar levels, most commonly affecting individuals with Type 2 diabetes. The condition may result in profound dehydration, neurological complications, seizures, coma or death.
• Hospitalization and emergency intervention: Both DKA and HHS often require urgent medical care, including intravenous fluids, insulin administration and treatment to restore electrolyte balance. Delays in care may increase the risk of serious long-term health consequences.
• Diabetic coma or fatal complications: In the most serious cases, defective pods that interrupt insulin delivery may lead to diabetic coma or death, particularly when users are unaware the device is no longer functioning correctly.

Omnipod Failure Indicators

The FDA has classified the Omnipod action as a Class I medical device recall, indicating use of the affected products may cause serious injuries or death.

Regulators say users of the affected pods may notice moisture on their skin or around the pod adhesive, or detect the odor of insulin leaking from the device. They also caution that the malfunction may not always be obvious and, in some cases, could occur without the user realizing it.

Insulet has instructed users not to use pods from affected lot numbers and to immediately check product packaging or pod tray labels to determine whether devices are included in the recall. The company warns that the risk of insulin under-delivery may increase if patients use more than one defective pod in succession.

The company is advising anyone currently using a pod from an affected lot to stop using it immediately and replace it with a pod from an unaffected lot. Customers can confirm whether their pod is included in the voluntary correction by visiting Insulet’s online lot checker. 

Consumers in the United States who experience adverse reactions, product defects or have questions about the recall can contact Insulet customer support at 1-800-641-2049 or speak with a representative through the live chat feature on the company’s website.

Federal regulators are advising users experiencing unexplained high blood sugar levels, nausea, vomiting, abdominal pain, confusion or difficulty breathing to seek immediate medical attention, as those symptoms may indicate diabetic ketoacidosis.

Omnipod Recall Lawsuits

Following the expanded Omnipod recall, lawyers nationwide are reviewing potential Omnipod 5 lawsuits on behalf of diabetic patients who suffered serious injuries allegedly caused by insulin delivery failures.

Individuals who have been injured after using an Omnipod 5 pod may be eligible to pursue compensation for medical expenses, pain and suffering and other damages, particularly in cases involving:

• Diabetic ketoacidosis (DKA)
• Hyperosmolar hyperglycemic state (HHS)
• Hospitalization
• Diabetic coma
• Other serious complications

Consumers who believe they may qualify for an Omnipod 5 lawsuit can request a free case evaluation, during which attorneys review the circumstances of the injury, discuss potential legal options and determine whether a claim may be pursued.

Attorneys handling Omnipod cases work on a contingency fee basis, meaning there are no fees or expenses unless a settlement or recovery is obtained.

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