Insulet Corporation recalls
6 federal recalls on file, showing the 2 from the last 12 months. We monitor every CPSC, FDA, USDA, and NHTSA notice for Insulet Corporation and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-07-08FDA-DeviceClass I3 productsInsulet Omnipod 5 Pods recalled for insulin leakage risk
Some Omnipod 5 insulin pump pods have a manufacturing defect in the soft cannula (the small tube that delivers insulin) that can cause insulin to leak outside the pod instead of being delivered into the body. This under-delivery of insulin can lead to high blood sugar levels. In severe cases, prolonged high blood sugar can result in diabetic ketoacidosis or other serious complications.
- 2026-04-22FDA-DeviceClass IStop using affected Omnipod 5 Pods immediately
Certain Omnipod 5 Pods from 49 specific manufacturing lots contain an internal tear in the soft cannula. This defect causes insulin to leak inside the Pod instead of being delivered to your body. In some cases, the Pod may shut down completely and stop delivering insulin, or deliver less insulin than needed.
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