7 Million Insulin Pumps Recalled Over Dangerous Defect, FDA Warns

If you have type 1 diabetes, you probably rely on an insulin pump to regulate your symptoms. But if you use an Omnipod pump, you should double-check that you’re getting the insulin you need—and consider trading your device in for another—as millions of the devices are being recalled nationwide.

According to the U.S. Food & Drug Administration’s announcement, the recall was initiated by Insulet Corporation, Inc. due to a potentially hazardous manufacturing issue. A “small tear” in the pump’s tubing could cause insulin to “leak outside of the Pod [sic] instead of being fully delivered into the body as intended, potentially leading to under-delivery of insulin,” per the FDA.

While this issue doesn’t affect the functionality of the device’s continuous glucose monitoring (CGM) and reading features, it’s still serious. The under-delivery of insulin could result in high blood sugar levels, which, if left untreated, could lead to life-threatening diabetic ketoacidosis (DKA). As of publishing, there have already been 24 reported “serious adverse events” resulting from use of the recalled pods, including some hospitalizations and instances of DKA. No deaths have been reported.

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