Omnipod 5 Recall: What Patients Need to Know

Insulet Corporation has initiated a voluntary medical device correction, impacting specific lots of its Omnipod 5 automated insulin delivery pods. The recall stems from a manufacturing issue that could lead to insulin leakage, potentially causing dangerously high blood glucose levels and, in severe cases, diabetic ketoacidosis (DKA). Here’s a breakdown of what patients need to know.

What’s the Problem?

Certain Omnipod 5 pods may have a tiny tear in the internal tubing responsible for delivering insulin. This tear can cause insulin to leak inside the pod instead of being infused into the body as intended. Insufficient insulin delivery can lead to hyperglycemia, and prolonged high blood glucose can escalate to DKA, a serious and potentially life-threatening condition requiring immediate medical attention. FDA Announcement

What Has Happened So Far?

As of March 13, 2026, Insulet has received 18 reports of serious adverse events, including hospitalizations and cases of DKA, potentially linked to this defect. MedPath News No deaths have been reported. The affected pods represent approximately 1.5% of the company’s annual global Omnipod 5 production. Brief Glance

Which Pods Are Affected?

The correction applies to specific lots of Omnipod 5 Pods. Insulet has stated that not all lots beginning with “PH1U” are affected. Patients are urged to visit omnipod.com/check-pods to enter their lot number and determine if their pods are included in the recall. The lot number can be found on the pod tray lid, the bottom of the pod, and on the 5-pack pod box. Daily Hornet

What Should Patients Do?

If you are using an Omnipod 5 pod included in the recall, you should remove it and replace it with a pod from an unaffected lot. Insulet is offering free replacement pods to affected users. You can request a replacement through the Omnipod website or by contacting Insulet Product Support at 800-641-2049 (available 24/7) or via live chat at omnipod.com/current-podders.

Are Other Omnipod Products Affected?

This voluntary medical device correction only impacts specific lots of Omnipod 5 Pods. All other Omnipod 5 Pods and other Omnipod products remain safe to leverage. Continuous glucose monitoring (CGM) systems and CGM readings are not affected by this recall. FDA Announcement

Looking Ahead

Insulet has stated that it has updated its manufacturing processes and quality controls to prevent this issue from recurring. The company anticipates the cost of this correction to be up to $40 million in 2026. Brief Glance Patients are encouraged to stay informed and follow the guidance provided by Insulet and the FDA.