Back to dashboard
All PlansAdministrativeMedium impact

Voluntary Medical Device Correction for Omnipod 5 Pods

Illinois Medicaid - HFS·IL · Endocrinology, Family Medicine, Internal Medicine +1 more·Provider Notice
Effective date
Apr 10, 2026
We identified it
Jun 16, 2026
Days to comply

Summary

Insulet has issued a voluntary medical device correction for select lots of Omnipod 5 Pods due to manufacturing defects that can cause insulin leakage. Affected pods should not be used and will be replaced at no cost without requiring new prescriptions.

Action Required

Action needed
Immediately: Notify patients using Omnipod 5 Pods to check their lot numbers at https://www.omnipod.com/mdc-3-26/check-pod-lot and discontinue use of affected pods. Providers should be prepared to offer alternative insulin delivery guidance for patients experiencing temporary supply interruptions. Contact Insulet at 1-800-641-2049 for product support or medicalinformation@insulet.com for clinical questions.