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# Insulet Class 1 Recall of Insulin Pump Components
- URL: https://www.fdaweb.com/insulet-class-1-recall-of-insulin-pump-components/
- Published: 2026-04-29T12:00:00.000Z
- Updated: 2026-09-14T13:38:17.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5161066

Insulet has recalled (Class 1) certain insulin pump components, warning that continued use could result in severe injury or death. The recall affects specific lots of the company’s Omnipod 5 Pods, a wearable device used to deliver insulin continuously for people with diabetes. According to an FDA [notice](https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/insulin-pump-recall-insulet-removes-certain-omnipod-5-pods?utm%5Fmedium=email&utm%5Fsource=govdelivery), Insulet is removing the affected pods from the market after identifying a defect that may interfere with proper insulin delivery.

Omnipod 5 is a tubeless insulin delivery system designed to provide automated, subcutaneous insulin dosing for individuals with diabetes who require insulin therapy.

Insulet says the issue stems from a potential small tear in the internal tubing of some pods. This defect can cause insulin to leak inside the device rather than being delivered into the body, leading to under-delivery of insulin. In turn, patients may experience elevated blood glucose levels. In the most serious cases, prolonged under-delivery could lead to diabetic ketoacidosis, a life-threatening condition requiring urgent medical care, according to the notice.

Complicating the risk, FDA notes that the malfunction may not always trigger an alarm. While some users may receive alerts indicating a fluid leak, others could remain unaware of the issue, increasing the likelihood of sustained high blood sugar levels. The risk may be higher if multiple affected pods are used consecutively.

As of 4/17, Insulet has reported 476 serious injuries and no confirmed deaths linked to the issue.