Tag: insulin_under_delivery

FDA Issues Early Alert on Insulet Omnipod Insulin Pump Under-Delivery Risk

4 Jun 2026 3:31 p.m. · Source: US Food and Drug Administration

The FDA has issued an Early Alert concerning Insulet Omnipod insulin pumps. Certain Pods may have a cannula tear, leading to insulin under-delivery. Affected models include Omnipod 5, DASH, and Eros, prompting a customer removal recommendation.

Health Business Science & Technology Medical Science Federal Government Insulet Omnipod Insulin Pump FDA Medical Device Product Recall Insulin Under-delivery Food Recalls Drugs
Insulet Issues Medical Device Correction for Omnipod Pods Over Insulin Under-Delivery Risk

27 May 2026 4:51 p.m. · Source: US Food and Drug Administration

Insulet Corporation announced a voluntary medical device correction for specific Omnipod Pods due to a manufacturing issue that could cause insulin under-delivery, potentially leading to high blood glucose or DKA. Approximately 7 million Pods are affected.

Health Business Politics and Government Medical Science Federal Government Economy Legal Insulet Corporation Omnipod Medical Device Correction Insulin Under-delivery Diabetic Ketoacidosis Product Recall Acton Food Recalls FDA Drugs