Insulet (PODD) said late Tuesday it initiated a voluntary medical device correction for certain Omnipod 5, Omnipod DASH, and Omnipod insulin management system pods due to a manufacturing defect.

The issue was identified during product monitoring and could result in insulin under-delivery, which may lead to diabetic ketoacidosis in severe cases, according to a statement.

The company said that some pods could have a tear in the tubing, which could result in insulin leakage. It has also executed corrective actions and bolstered its quality control processes to prevent recurrence.

In a separate regulatory filing, Insulet said it expects to incur up to $50 million of costs in 2026 linked with the correction but is reaffirming its annual guidance.