Insulet Corporation: Device Recall

Recall #Z-2016-2025 · 05/23/2025

Class II: Risk

Recall Details

Recall Number: Z-2016-2025
Classification: Class II
Product Type: Device
Recalling Firm: Insulet Corporation
Status: Ongoing
Date Initiated: 05/23/2025
Location: Acton, MA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 122,823 downloads

Reason for Recall

Insulet Corporation is recalling Omnipod 5 iOS App, due to a software design issue in which a comma is not recognized as a decimal separator and the user cannot enter a decimal separator in any manual entry screen if the user manually updates their phone settings to a region OUS that uses a decimal separator instead of a period decimal separator or chooses that format as a preference. Use of the affected software may result in over delivery of insulin by increasing the amount of insulin when a decimal separator is not recognized (e.g., 0.1 unit recognized as 1 unit) and thus may result in hypoglycemia, potentially severe.

Product Description

Omnipod 5 Automated Insulin Delivery System, iOS Application. Model Number: PT-000664/M009-S-AP. Software Version: all Product Description: The Omnipod 5 iOS App software is available to download through the Apple app store. The Omnipod 5 App is the user interface that controls the Omnipod 5 Automated Insulin Delivery System. It is used to activate/deactivate Pods, display alerts/alarms, and send insulin delivery commands for execution to the Pod. Only available in the US.

Distribution Pattern

US market only- Although there are 122823 downloads of the application, our data shows there are only ~80k active users.

Other Recalls by Insulet Corporation

Class II: Risk 09/11/2025

The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a manual entry field, to magnify the visual field using the magnifying feature of the iPhone, while simultaneously selecting a single number on the keyboard. This causes the single digit number to duplicate. This could result in errors in manual entry of digits - examples: bolus entry, I:C ratio, bolus calculator, prior to starting the bolus insulin delivery. Therefore, this may result in over delivery of insulin which may cause hypoglycemia.

View all recalls by Insulet Corporation →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.