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Were You or a Loved One Injured After Using a Recalled Omnipod® 5 Insulin Pump Pod?
The FDA has issued safety communications regarding certain recalled Omnipod® 5 insulin pump Pods due to a manufacturing defect that may cause the device to deliver less insulin than intended. According to the FDA, insulin under-delivery can lead to dangerously high blood sugar, diabetic ketoacidosis (DKA), hospitalization, and other serious health complications.
If you or a loved one experienced diabetic ketoacidosis, severe hyperglycemia, hospitalization, another serious injury, or if you lost a loved one after using an affected Omnipod® insulin pump Pod, you may have legal options. Levin Papantonio is investigating claims involving recalled Omnipod® insulin pump Pods.
For a free case evaluation, fill out our form here or call 800.277.1193.
Omnipod® 5 is a wearable, tubeless insulin delivery system designed to automatically deliver insulin for people living with diabetes.
In March 2026, Insulet announced a voluntary Medical Device Correction affecting certain Omnipod® 5 Pods after identifying a manufacturing defect involving a small tear in the Pod’s internal tubing. According to the company and the FDA, this defect could allow insulin to leak inside or outside the Pod rather than be delivered into the body, resulting in under-delivery of insulin.
In May 2026, Insulet expanded the correction to include additional Omnipod® 5 Pods, Omnipod® DASH Pods, and Omnipod® Insulin Management System (Eros) Pods distributed in the United States and internationally after identifying a similar manufacturing issue. Approximately seven million Pods were included in this expanded action.
When insulin is not delivered properly, blood glucose levels may rise quickly.
According to the FDA, prolonged insulin under-delivery can lead to:
According to Insulet and the U.S. Food and Drug Administration (FDA), the recalls were issued after the manufacturer identified manufacturing defects in certain Omnipod® insulin pump Pods that could interfere with proper insulin delivery.
If this occurs:
Because of these risks, the FDA classified the Omnipod® 5 recall as a Class I recall, the agency’s most serious recall designation.
You may qualify to pursue a claim if you:
Every situation is different, and eligibility depends on the specific facts of each case.
June 4, 2026
The FDA issued an Early Alert announcing that Insulet had expanded its voluntary Medical Device Correction to include certain Omnipod® 5 Pods, Omnipod® DASH Pods, and Omnipod® Insulin Management System (Eros) Pods. Approximately 7 million Pods were included in the expanded action after the manufacturer identified a defect that could lead to insulin underdelivery. The FDA reported 24 serious injuries, including hospitalizations and diabetic ketoacidosis (DKA), but no deaths. Users were advised to stop using affected Pods and obtain replacements.
April 29, 2026
The FDA classified the Omnipod® 5 Pod recall as a Class I recall, the agency’s most serious recall designation. According to the FDA, insulin under-delivery may result in severe hyperglycemia, diabetic ketoacidosis (DKA), hospitalization, or death if left untreated.
March 13, 2026
Insulet initiated a voluntary Medical Device Correction for certain lots of Omnipod® 5 Pods after identifying a manufacturing defect involving small tears in the Pod’s insulin delivery tubing. The defect could cause insulin to leak before reaching the user, resulting in insulin under-delivery and an increased risk of dangerously high blood sugar and diabetic ketoacidosis. The company instructed customers to discontinue use of affected Pods and request replacements.
For more than 70 years, Levin Papantonio has represented individuals and families harmed by defective medical devices, dangerous prescription drugs, and other unsafe consumer products.
The firm has helped recover more than $80 billion in verdicts and settlements and has played a leadership role in many of the nation’s largest and most complex product liability cases. Levin Papantonio has represented clients in litigation involving defective medical devices, insulin-related products, drug delivery systems, hip implants, hernia mesh, transvaginal mesh, CPAP machines, defective knee and shoulder implants, and numerous dangerous pharmaceutical products.
Our attorneys continue to investigate claims involving defective medical devices and work to hold manufacturers accountable when patients suffer preventable injuries.
If you or someone you love experienced diabetic ketoacidosis, required hospitalization, suffered another serious complication, or lost a loved one after using a recalled Omnipod® insulin pump Pod, you can request a free, confidential case evaluation to learn more about your legal options.
The March 2026 Medical Device Correction affected certain Omnipod® 5 Pods. In May 2026, Insulet expanded the correction to include certain Omnipod® 5, Omnipod® DASH, and Omnipod® Insulin Management System (Eros) Pods.
According to the FDA and Insulet, certain Pods may have manufacturing defects that can result in insulin under-delivery due to tears in the insulin delivery tubing
Diabetic ketoacidosis (DKA) is a serious medical emergency that can occur when the body does not receive enough insulin. Symptoms may include excessive thirst, nausea, vomiting, abdominal pain, confusion, rapid breathing, and high blood glucose levels. Prompt medical treatment is essential.
Yes. The FDA classified the Omnipod® 5 recall as a Class I recall, the agency’s most serious recall classification.
Individuals who suffered injuries related to a recalled medical device may be able to seek compensation for medical expenses, lost wages, pain and suffering, and other damages, depending on the facts of their case.
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