Recalled Omnipod 5 Injuries Skyrocket, Prompting Removal of Insulin Pump Pods

Insulet has announced a surge in reports of insulin delivery failures linked to Omnipod 5 pods, raising concerns about risks of diabetic ketoacidosis and other serious complications.

Certain Omnipod 5 insulin pump pods are being removed from use by the manufacturer, following a sharp increase in reports that the devices may fail to deliver insulin as intended.

According to a safety communication issued by the U.S. Food and Drug Administration (FDA) on April 29, Insulet Corporation is removing affected Omnipod 5 pods from use after identifying problems that could place users at risk of serious and life-threatening complications.

Omnipod 5 Injuries

The current action follows an Omnipod 5 insulin pump recall announced in March 2026, when regulators alerted the public to concerns involving pod malfunctions and insulin delivery interruptions. However, at the time, there were only 18 reported injuries. That number has since risen dramatically to 476.

Omnipod 5 systems are widely used by individuals with diabetes to provide automated insulin delivery through a wearable pod that communicates with a controller or smartphone. When functioning properly, the system continuously adjusts insulin levels based on glucose readings. However, when insulin delivery is disrupted, users may rapidly develop dangerously high blood sugar levels.

Following the recall, attorneys nationwide are investigating Omnipod 5 lawsuits involving allegations that pod failures caused severe hyperglycemia, diabetic ketoacidosis (DKA) and other complications requiring emergency medical treatment.

Omnipod 5 Failure Injury Risks

The updated Omnipod 5 recall affects specific lots of disposable pods distributed nationwide, with the unique device identifier (UDI): 10385083000527. Lot numbers can be checked on the Omnipod website.

Federal regulators warn that the affected devices may malfunction without warning, potentially stopping insulin delivery or causing users to receive less insulin than needed. Since the recall was first announced, the number of reported injuries has skyrocketed from 18 to more than 400, raising growing concerns about the risk of serious and potentially life-threatening complications.

Potential injuries linked to the Omnipod 5 pod failures may include:

• Severe hyperglycemia: If the pod stops delivering enough insulin, blood sugar levels may rise to dangerous levels before the user realizes there is a problem. The FDA indicates that users may not immediately recognize when insulin delivery has been interrupted, increasing the risk of delayed treatment.
• Diabetic ketoacidosis (DKA): DKA is a medical emergency that occurs when the body does not have enough insulin to use glucose for energy. The body begins breaking down fat instead, producing dangerous levels of ketones in the blood. Warning signs may include nausea, vomiting, abdominal pain, confusion, rapid breathing and fruity-smelling breath. Without prompt treatment, DKA can lead to severe dehydration, organ damage or death.
• Hyperosmolar hyperglycemic state (HHS): HHS is another serious complication caused by extremely high blood sugar levels, more commonly seen in individuals with Type 2 diabetes. Unlike DKA, it usually does not involve significant ketone buildup, but it can still cause severe dehydration, thickened blood, confusion, seizures, coma or death.
• Hospitalization and emergency treatment: Both DKA and HHS require immediate medical care, often involving IV fluids, insulin therapy and correction of electrolyte imbalances. Many patients require hospitalization, and treatment delays may increase the risk of long-term complications.
• Diabetic coma or death: In severe cases, interruptions in insulin delivery caused by defective devices may result in diabetic coma or fatal outcomes, particularly if users are unaware that the pod has stopped working properly.

Patients are being advised to stop using affected pods and switch to alternative insulin delivery methods. Health care providers are also being urged to closely monitor patients who may have been impacted by the recall.

U.S. customers who experience adverse events, product quality problems or have questions about the recall can contact Insulet at 1-800-641-2049 or use the live chat feature available on the company’s website. The FDA also recommends that adverse events or product quality issues be reported through MedWatch, the agency’s Safety Information and Adverse Event Reporting Program.

Omnipod 5 Lawsuits

Investigations into potential Omnipod 5 lawsuits are underway nationwide, with claims focusing on whether Insulet failed to properly warn patients and health care providers about the risk of insulin delivery failures despite growing reports of device problems.

Individuals who developed complications after using an Omnipod 5 pod may be able to seek compensation for medical bills, pain and suffering, and other losses, particularly in cases involving:

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

Those who believe they may qualify for an Omnipod 5 lawsuit can request a free case review, during which an attorney will evaluate the circumstances, explain available legal options and determine eligibility to pursue compensation.

Attorneys handling these cases typically work on a contingency fee basis, meaning there are no upfront costs and fees are only paid if a recovery is obtained.

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