The Recall Desk
SevereFDA (Devices)·Z-2016-2025·Announced 2025-07-02

Omnipod 5 iOS App software design issue causes insulin overdose risk

Insulet Corporation is recalling the Omnipod 5 iOS App due to a software issue where decimal separators are not recognized in manual insulin entry, potentially causing insulin overdose and severe hypoglycemia.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this as Class II. The defect directly enables insulin overdose, which could cause severe hypoglycemia—a serious adverse health consequence. Although no illnesses are reported in the source text, the mechanism of harm is confirmed and potentially severe, meeting the Class II + serious health risk criterion for a Severe rating.

Plain-English summary

Insulet Corporation is recalling the Omnipod 5 Automated Insulin Delivery System iOS Application (Model Number PT-000664/M009-S-AP, all software versions 1.X.X) due to a software design defect. The application fails to recognize commas as decimal separators and does not allow users to enter a decimal separator on manual entry screens if they have manually changed their phone settings to a region that uses a comma as the decimal separator instead of a period, or have selected that format as a preference.

When the decimal separator is not recognized, the software may incorrectly increase the insulin dose. For example, a user intent to enter 0.1 unit may be processed as 1 unit. This miscalculation could result in over-delivery of insulin and potentially severe hypoglycemia.

The Omnipod 5 iOS App is available only in the US through the Apple App Store and is used to activate and deactivate insulin delivery Pods, display alerts and alarms, and send insulin delivery commands to the Pod. Users who have changed their phone's regional settings to use a comma as a decimal separator should check their device settings and be aware of this potential risk when using manual insulin entry.

Affected users should contact Insulet Corporation for instructions on how to address this issue or update their app when a corrected version becomes available.

The recalled product

Product
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 t
Manufacturer
Insulet Corporation
Category
Medical Device — Insulin Delivery System
Hazard
  • insulin-overdose
  • hypoglycemia
  • software-defect

Distribution

Distribution scope not specified by the agency.

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