The recall follows concerns that some pods may fail to deliver the intended amount of insulin, increasing the risk of dangerously high blood sugar levels and diabetic ketoacidosis (DKA).
Omnipod devices deliver insulin subcutaneously at programmed and variable rates for people with diabetes who require insulin therapy.
FDA Urges Users To Stop Using Affected Pods
The FDA said on Thursday the recall calls for removing specific Omnipod pods from where they are used or sold.
The affected products include the Omnipod 5 Automated Insulin Delivery System, Omnipod DASH Insulin Management System and Omnipod Insulin Management System (Omnipod Eros).
