Insulet Initiates Voluntary Medical Device Correction for Certain Omnipod® Pods in the U.S. and Affected International Markets

Date

May 26, 2026

Company

Insulet Corporation, Inc.

Brand

Omnipod

Product

Device intended for the subcutaneous delivery of insulin into a patient

Reason

Manufacturing issue that could result in under delivery of insulin

Hazard

Other

Source

FDA

How to identify the product

• This action is separate from the voluntary Medical Device Correction issued on March 12, 2026 affecting certain Omnipod 5 Pods in the U.S. and includes certain Pod lots distributed in the U.S. and affected international markets.
• Customers should visit Check Pod Lot 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.

Official notice (FDA)

Facts are taken from the official notice. If anything here differs from it, the official notice is correct.