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# Insulet Omnipod Pod Recall is Class 1: FDA
- URL: https://www.fdaweb.com/insulet-omnipod-pod-recall-is-class-1-fda/
- Published: 2026-07-06T12:00:00.000Z
- Updated: 2026-09-14T13:42:16.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5161400

FDA says the Insulet 5/26 recall of certain Omnipod Pods is Class 1\. An agency [notice](https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/insulin-pump-recall-insulet-removes-omnipod-pods?ref=fdaweb.com) says Insulet identified that some pods from specific lots may have a small tear in the cannula just above the skin, between the Pod and the point where the cannula enters the body. If such a tear occurs, the notice says, insulin may leak outside of the Pod instead of being fully delivered into the body as intended, potentially leading to under-delivery of insulin. If insulin leakage occurs, FDA says, blood glucose levels may rise and may not respond as expected to insulin delivery.

As of 5/24, Insulet had reported 24 serious injuries and no deaths associated with the issue.