Tag: medical_device_correction

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