---
title: "Omnipod 5 Automated Insulin Delivery System, iOS Application. Model Number: P... — FDA record Z-2016-2025 | Is It on Recall"
description: "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"
url: https://isitonrecall.com/recall/fda-device-z-2016-2025-omnipod-5-automated-insulin-delivery-system-ios-application-model-number-pt-000664-m009-s-ap-softwar/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# Omnipod 5 Automated Insulin Delivery System, iOS Application. Model Number: PT-000664/M009-S-AP. Software Version: al... — FDA record Z-2016-2025

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date May 23, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **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 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.
- **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 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.
- **Classification**: Class II
- **Recalling firm**: Insulet Corporation
- **Quantity**: 122,823 downloads
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-2016-2025

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2016-2025%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | Model Number: PT-000664/M009-S-AP. UDI-DI: 10385083000336. All software versions 1.X.X |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

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

No US distribution state could be established from this record. Check the official notice.

## Dates in the source

- **Report date**: Jul 2, 2025
- **Recall initiation date**: May 23, 2025
- **Center classification date**: Jun 24, 2025

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2016-2025%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Insulet Corporation records](https://isitonrecall.com/brand/insulet-corporation/)