FDA Updates Class I Recall for Omnipod 5 Insulin Pumps Due to Under-Delivery Risk

Published: 2026-04-29
Category: health
Source: U.S. Food and Drug Administration (FDA)
Original source

The U.S. Food and Drug Administration has issued an updated Class I recall for specific lots of Insulet Omnipod 5 Pods. The recall is due to a potential defect in the internal tubing that could lead to insulin leakage and insufficient delivery. This issue poses a serious health risk, potentially causing dangerously high blood glucose levels or life-threatening diabetic ketoacidosis.

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