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Elizabeth M. Whitehorn, Director

Provider Notice issued 04/10/2026

 Voluntary Medical Device Correction for Omnipod 5 Pods

To:
 Enrolled Pharmacies, Physicians, and Nurses
​Date: ​April 10, 2026
​Re:
  Voluntary Medical Device Correction for Omnipod 5 Pods

This notice is to inform providers that Insulet has issued a voluntary Medical Device Correction for select lots of Omnipod 5 Pods due to a manufacturing issue. Some Pods may contain a small tear in the internal insulindelivery tubing, which can cause insulin to leak within the Pod rather than be delivered as intended.

This notice applies only to specific Omnipod 5 Pod lots distributed in the United States. Continuous glucose monitoring (CGM) devices and CGM readings are not affected.

Customers can verify if their Pod lot is affected by visiting the link below. Lot numbers can be found on the Pod lid, the bottom of the Pod, as well as on the 5-Pod packaging. There may be multiple Pods from the same affected lot within a single box. Pods from affected lots should not be used.

Insulet will replace impacted Pods at no cost. A new prescription is not required, and Insulet reports having adequate supply to fulfill replacements without affecting overall product availability. If patients experience a temporary interruption in Pod supply, they should contact their healthcare provider for guidance on alternative insulin delivery options until replacement Pods are received.

Patient Support and Replacement Requests

  • Product Support (24/7): 18006412049 

For clinical questions or to request additional outreach materials, contact Insulet Medical Affairs at: medicalinformation@insulet.com.

Questions regarding this notice may be directed to the Bureau of Professional and Ancillary Services at 877-782-5565, or the applicable MCO.

 

 

Laura Phelan, Administrator
Division of Medical Programs