Insulet initiates voluntary correction for 7M Omnipod units due to insulin under-delivery risk.

Insulet Corporation announced a voluntary medical device correction for approximately 7 million Omnipod pods across multiple product lines due to a manufacturing defect causing potential insulin under-delivery, with 24 serious adverse events reported globally including hospitalizations and diabetic ketoacidosis cases. The correction affects 8.5% of 2025 global production, but the company has sufficient replacement supply and does not anticipate product availability disruptions, representing a significant quality issue that may impact customer confidence and operational costs.