Omnipod 5 Automated Insulin Delivery System, iOS Application. Model Number: PT-000664/M009-S-AP. Software Version
Summary
The FDA issued a Class II for Omnipod 5 Automated Insulin Delivery System, iOS Application. Model Number: PT-0 by Insulet Corporation. Reason: 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 u.
Details
Source
Device Recall
External ID
Z-2016-2025
Action Date
2025-07-02
Status
Ongoing
Category
device
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.
Lot/Code Info: Model Number: PT-000664/M009-S-AP. UDI-DI: 10385083000336. All software versions 1.X.X
Quantity Affected: 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.
Distribution
US market only- Although there are 122823 downloads of the application, our data shows there are only ~80k active users.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-05-23
Company
Acton, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 160 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Insulet Corporation has 17 FDA actions in our database, including 7 recalls and 10 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Insulet Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Insulet Corporation have FDA actions?
Insulet Corporation has 17 FDA actions in our database, including 7 recalls and 10 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2016-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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