# FDA recall Z-2016-2025

> **Insulet Corporation** · Class II · device recall initiated 2025-05-23.

## 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 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.

## Key facts

- **Recall number:** Z-2016-2025
- **Recalling firm:** Insulet Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-05-23
- **Report date:** 2025-07-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Acton, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2016-2025

## Citation

> AI Analytics. FDA recall Z-2016-2025. Retrieved 2026-05-29 from https://api.ai-analytics.org/recall/Z-2016-2025. Source: US FDA. Licensed CC0.

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