FDA Update: Insulet Initiates Voluntary Medical Device Correction for Certain Omnipod® 5 Pods in the U.S.
Published: 03/16/2026
Sources:
- Food and Drug Administration
Relevant To:
- Ambulatory Surgical Centers,
- Rural Emergency Hospitals,
- Urgent Care,
- Medical Office,
- Critical Access Hospitals,
- Home Health,
- Hospitals,
- Long Term Care,
- Ambulatory Care,
- Rural Health Clinics
FDA Update:
- Insulet Initiates Voluntary Medical Device Correction for Certain Omnipod® 5 Pods in the U.S.
- Summary - Pods may have a small tear in the internal tubing that delivers insulin. This may leak inside the Pod instead of being fully infused into the body as intended.