Insulin-delivery device maker Insulet said it has initiated a recall of specific batches of its Omnipod 5 insulin pods in the United States after identifying a manufacturing issue that could prevent users from receiving their full insulin dose.
The company disclosed the action, stating that the defect involves a small tear in internal tubing inside the device. This flaw can cause insulin to leak into the wearable pod instead of being delivered into the body, potentially leaving users without the intended dose of the blood sugar-regulating hormone.
The affected product, the Omnipod 5, is an automated insulin delivery system designed to be worn on the skin by people with diabetes. The device administers insulin through a pod-based system and works alongside compatible continuous glucose monitoring devices.
According to the company, the manufacturing problem could result in elevated blood sugar levels for patients if insulin is not delivered correctly. In more serious situations, it could lead to diabetic ketoacidosis, a condition in which the body begins breaking down fat rapidly and requires urgent medical treatment.
Insulet reported that it has received 18 reports of serious adverse events connected to the issue. These cases include hospitalizations associated with prolonged high blood sugar levels and diabetic ketoacidosis. The company said that no deaths have been reported in connection with the defect.
The company said the problem has been traced to a tear in the internal tubing of the pod. It also clarified that the defect does not interfere with connected continuous glucose monitoring systems or the accuracy of their readings.
“Users can check to see if their pump is included by searching for the specific lot number on the company’s website,” Insulet said.
Customers whose devices are included in the recall are advised to stop using the affected pods and request replacements from the company. Insulet stated that replacement units will be provided at no cost to affected users.
The company emphasized that only certain production lots are impacted by the issue. It added that all other Omnipod products remain safe for use. The defective units represent approximately 1.5% of the company’s annual global production.
Insulet said it has informed the U.S. Food and Drug Administration about the recall. The company also indicated that manufacturing and shipments of new Omnipod 5 units will continue without interruption.
The Omnipod 5 system was first launched in the United States and Europe in 2022. In August 2024, the FDA cleared the device as the agency’s first automated insulin pump designed for people with Type 2 diabetes. The product is currently available in 19 countries and is compatible with glucose monitoring systems made by Dexcom and Abbott Laboratories.
In its most recent annual report, Insulet listed two highly automated manufacturing facilities located in Acton, Massachusetts, and Johor, Malaysia. The company is also developing a third production site in Costa Rica. In addition, it works with a contract manufacturer in China that supplies a significant share of its inventory.
For the 2025 financial year, Insulet reported that approximately 70% of its revenue came from sales in the United States.
Overview of the Insulet Recall
Insulet has announced a recall of specific Omnipod 5 insulin pods after identifying a defect that may lead to the under-delivery of insulin. This Insulet recall raises important concerns for diabetes patients relying on automated insulin delivery systems. The affected Insulet Omnipod 5 pods may not consistently deliver the programmed dose, potentially impacting blood glucose control.
What Caused the Insulet Pod Defect?
According to Insulet, the issue is linked to a manufacturing defect that interferes with insulin flow. This Insulet defect could result in patients receiving less insulin than required, increasing the risk of hyperglycemia. Insulet is actively investigating the root cause and implementing corrective measures to prevent future occurrences.
