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URGENT: Field Safety Corrective Action for Omnipod Pods, May 27, 2026

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©2018-2026 Insulet Corporation. Omnipod, the Omnipod logos, DASH, the DASH logo, the Omnipod 5 logo, SmartAdjust, Omnipod DISPLAY, Omnipod VIEW, Omnipod DEMO, Podder, Simplify Life, Toby the Turtle, PodderCentral, the PodderCentral logo, Podder Talk, PodPals, Pod University, and OmnipodPromise are trademarks or registered trademarks of Insulet Corporation. All rights reserved. Glooko is a trademark of Glooko, Inc. and used with permission. Dexcom and Dexcom G7 are registered trademarks of Dexcom, Inc. and used with permission. The sensor housing, FreeStyle, Libre, and related brand marks are marks of Abbott and used with permission. The Bluetooth® word mark and logos are registered trademarks owned by the Bluetooth SIG, Inc., and any use of such marks by Insulet Corporation is under license. All other trademarks are the property of their respective owners. The use of third-party trademarks does not constitute an endorsement or imply a relationship or other affiliation.

Intended Purpose as per Instructions for Use for The Omnipod 5 Automated Insulin Delivery System:

The Omnipod 5 Automated Insulin Delivery System is a single hormone insulin delivery system intended to deliver U-100 insulin subcutaneously for the management of type 1 diabetes in persons aged 2 and older requiring insulin. The Omnipod 5 System is intended to operate as an automated insulin delivery system when used with compatible Continuous Glucose Monitors (CGM). When in Automated Mode, the Omnipod 5 System is designed to assist people with type 1 diabetes in achieving glycaemic targets set by their healthcare providers. It is intended to modulate (increase, decrease or suspend) insulin delivery to operate within predefined threshold values using current and predicted sensor glucose values to maintain blood glucose at variable target glucose levels, thereby reducing glucose variability. This reduction in variability is intended to lead to a reduction in the frequency, severity, and duration of both hyperglycaemia and hypoglycaemia. The Omnipod 5 System can also operate in a Manual Mode that delivers insulin at set or manually adjusted rates. The Omnipod 5 System is intended for single patient use. The Omnipod 5 System is indicated for use with U-100 rapid acting insulin.

Warning: DO NOT start to use the Omnipod® 5 System or change settings without adequate training and guidance from a healthcare provider. Initiating and adjusting settings incorrectly can result in over delivery or under-delivery of insulin, which could lead to hypoglycaemia or hyperglycaemia.

Intended Purpose as per Instructions for Use for The Omnipod DASH® Insulin Management System:

The Omnipod DASH® Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin. The Omnipod DASH® System is indicated for use with U-100 rapid acting insulin.

Warning: Do NOT attempt to use the Omnipod DASH System before you receive training. Inadequate training could put your health and safety at risk.