Insulet (PODD) is moving lower as investors digest a voluntary U.S. medical device correction for specific lots of Omnipod 5 Pods after the company identified a manufacturing issue via product monitoring. The defect can create a small tear in internal tubing, potentially causing insulin to leak inside the pod and resulting in under-delivery, which can lead to high blood glucose and, in severe cases, diabetic ketoacidosis.

Insulet said it has received 18 reports of serious adverse events tied to high blood glucose levels, including hospitalization and diabetic ketoacidosis, with no deaths reported. The company said the FDA has been notified, that the action applies only to identified lots distributed in the U.S., and that other Omnipod 5 Pods and other Omnipod products remain safe to use.

Insulet expects up to $40 million of costs related to the correction, all in 2026, while stating it is not changing previously issued 2026 financial guidance and that the costs will be excluded from adjusted results. Key swing factors now are whether the correction remains limited to the currently identified lots, whether patient and provider confidence is affected, and whether any incremental quality actions create friction in Omnipod 5 growth or supply—even as the company says it does not anticipate disruptions to shipments, availability, or new patient starts.