Insulet recalls 7 million Omnipod insulin pumps due to leakage risk

Insulet Corporation (NASDAQ: PODD) announced a voluntary medical device correction affecting approximately 7 million Omnipod insulin pump pods due to a manufacturing defect that could cause insulin under-delivery.

The recall covers specific lots of Omnipod 5, Omnipod DASH, and Omnipod Insulin Management System pods distributed in the U.S. and international markets. The affected pods represent about 8.5% of the company's 2025 global Omnipod pod production, with approximately 60% of the recalled units already consumed or expired.

The manufacturing issue involves small tears in the tubing just above the skin between the pod and where the cannula enters the body. This defect can cause insulin to leak outside the pod instead of being delivered into the body, potentially leading to high blood glucose levels.

Users may notice wetness on their skin or pod adhesive or detect the smell of insulin, though the company stated the issue may sometimes go undetected. In severe cases, prolonged high blood glucose levels could lead to diabetic ketoacidosis, a serious condition requiring immediate medical treatment.

Globally, there have been 24 reports of serious adverse events associated with high blood glucose levels, including hospitalization and diabetic ketoacidosis. No deaths have been reported in connection with this issue.

Insulet identified the cause through ongoing product monitoring and has implemented corrective actions to prevent recurrence. The company has also strengthened its quality controls to detect similar cannula tears.

The FDA and other regulatory authorities have been notified of the action. Insulet is providing replacement pods at no cost and states it has sufficient supply to avoid disruption to product availability. The issue does not affect continuous glucose monitoring systems or readings.

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