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U.S. Department of Health and Human Services

Class 2 Device Recall Omnipod 5 Automated Insulin Delivery System

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 Class 2 Device Recall Omnipod 5 Automated Insulin Delivery Systemsee related information
Date Initiated by FirmMay 23, 2025
Date PostedJune 24, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2016-2025
Recall Event ID 96945
510(K)NumberK231826 
Product Classification Continuous glucose monitor informed insulin dose calculator - Product Code QRX
ProductOmnipod 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.
Code Information Model Number: PT-000664/M009-S-AP. UDI-DI: 10385083000336. All software versions 1.X.X
FEI Number 3014585508
Recalling Firm/
Manufacturer		 Insulet Corporation
50 & 100 Nagog Park
Acton MA 01720-3440
For Additional Information ContactAngela Geryak Wiczek
978-600-7451
Manufacturer 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.
FDA Determined
Cause 2		Software design
ActionInsulet notified health care professionals and users on 05/23/2025 via emailed letter. Consignees were instructed to make sure your phone s keyboard and region settings match the approved country for use currently, the U.S. only and this issue does not affect the Insulet-provided Omnipod 5 Controllers or the Omnipod 5 App on compatible Android phones. A software update will be pushed to all devices in the coming weeks, and each consignee will be notified via email and in-app notification on the device when it is ready to install. The fix will allow commas to be recognized as decimal points when using the Omnipod 5 App for iPhone. The email notification to users included a section to formally acknowledge the notification.
Quantity in Commerce122,823 downloads
DistributionUS market only- Although there are 122823 downloads of the application, our data shows there are only ~80k active users.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = QRX
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