Insulet Initiates Voluntary Medical Device Correction for Certain Omnipod® 5 Pods in the U.S.
- Date
- Mar 12, 2026
- Company
- Insulet Corporation
- Brand
- Omnipod
- Product
- Alternate controller enabled insulin infusion pump
- Reason
- 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.
- Hazard
- Other
- Source
- FDA
How to identify the product
- This action applies to specific identified lots distributed in the United States, and all other Omnipod® 5 Pods and Omnipod® products remain safe to use.
- Customers should visit omnipod.com/check-pods to confirm whether their Pod lot number is included in this voluntary Medical Device Correction and request replacement Pods at no cost.
- If a Pod from an affected lot is currently in use, customers should discontinue use and replace it with a Pod from an unaffected lot.
Facts are taken from the official notice. If anything here differs from it, the official notice is correct.