Omnipod 5 Recall: Insulet Reports 18 Adverse Events Linked to Insulin Delivery Issue

Insulet recalls small proportion of its Omnipod 5 insulin patch pump pods after identifying a manufacturing issue that could lead to under-delivery of insulin.

Insulet has announced a recall after identifying a manufacturing issue saying pods from specific production lots may contain a small tear in internal tubing inside the device. When this occurs, insulin may leak inside the pod instead of being delivered into the body.

Insulet reported 18 serious adverse events linked to high blood glucose levels associated with the issue. These included hospitalisation and cases of diabetic ketoacidosis. The company said it has not received reports of deaths related to the problem.

The recall affects an estimated 1.5% of Insulet’s annual global manufacturing volume of Omnipod 5 pods.

Affected customers are being contacted by the company and offered replacement pods at no cost. Insulet said it has also implemented updates to manufacturing processes and quality control following its investigation.

The company expects the recall to result in costs of up to $40 million during 2026. Insulet said the recall does not change its financial outlook and it continues to expect revenue growth of 20% to 22% for the year on a constant currency basis.

Insulet also stated that the recall is not expected to disrupt shipments, product availability or new patient starts for Omnipod 5.

What should people do if they think their Omnipod 5 pods are affected?

Anyone using Omnipod 5 who believes they may have pods from the affected production lots should contact Insulet customer support or their diabetes care team. The company is providing replacement pods and can confirm whether specific pods are included in the recall.

Users experiencing unexplained high glucose levels while wearing a pod should check the device and follow guidance from their healthcare team.

Recent safety issues in diabetes technology

The recall follows several recent safety developments in diabetes technology. These include warning letters relating to leaking infusion sets supplied by Unomedical, accuracy concerns raised about glucose sensors produced by Abbott, and safety reports involving insulin pump systems developed by Beta Bionics.

For people using insulin pumps and hybrid-closed loop systems, monitoring glucose levels and responding quickly to unexpected high readings remains important, particularly when insulin delivery issues are suspected.