Reported Jul 2, 2025 · Ongoing
Omnipod 5 Automated Insulin Delivery System, iOS Application. Model Number: PT-000664/M009-S-AP. Software Version: all…
Insulet Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Insulet Corporation · 50 & 100 Nagog Park · Acton, MA · 01720-3440
Is this the product you have?
- Omnipod 5 Automated Insulin Delivery System, iOS Application
- Model NumberPT-000664/M009-S-AP
- Software Versionall
- Product DescriptionThe 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 codes and dates
- Model NumberPT-000664/M009-S-AP
- UDI-DI10385083000336. All software versions 1.X.X
- Amount recalled
- 122,823 downloads
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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