FDA
Omnipod Pod recall: Tubing defect raises risk of silent insulin underdelivery
Clinical Takeaway: Assess patients using Omnipod systems for affected lots and unexplained hyperglycemia—device-related insulin underdelivery may occur without alarms and can precipitate DKA.
Insulet has issued a voluntary medical device correction for certain lots of Omnipod® 5, Omnipod DASH®, and Omnipod Eros insulin delivery Pods due to a manufacturing defect that can compromise insulin delivery.
The issue stems from a small tear in the Pod’s cannula/tubing, which can allow insulin to leak rather than be fully infused subcutaneously, leading to underdelivery. In some cases, leakage may be noticeable (e.g., wetness or insulin odor), but the defect can also be subtle or undetected and not always trigger device alarms.
Clinically, inadequate insulin delivery can result in sustained hyperglycemia and, in severe cases, diabetic ketoacidosis (DKA), a potentially life-threatening complication requiring urgent treatment. Globally, 24 serious adverse events—including hospitalization and DKA—have been reported, though no deaths have occurred.
Approximately 7 million Pods (≈8.5% of 2025 production) are affected; many may already have been used or expired. FDA has flagged similar Omnipod recalls as high-risk due to the potential for serious harm if defective devices continue to be used.
Why this matters: For clinicians managing patients with diabetes—particularly those using automated insulin delivery—this recall introduces a device-related cause of unexplained hyperglycemia. Patients may present with persistently elevated glucose levels despite adherence or appropriate dose adjustments. Because alarms may not reliably signal the defect, clinicians should maintain a high index of suspicion.
Patients should be advised to check Pod lot numbers, discontinue affected devices, and switch to unaffected Pods or alternative insulin delivery methods if needed. Reinforce frequent glucose monitoring and prompt evaluation for DKA symptoms during this transition.
Source: FDA. May 26, 2026. Insulet Initiates Voluntary Medical Device Correction for Certain Omnipod® Pods in the U.S. and Affected International Markets