FDA Device recall Z-2016-2025
Omnipod 5 Automated Insulin Delivery System, iOS Application
- FDA Device
- Class II
- ongoing
- Published 2025-07-02
On 2025-07-02 the FDA classified a Class II recall of Omnipod 5 Automated Insulin Delivery System, iOS Application by Insulet, citing 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 se….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2016-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-05-23 |
| Published | 2025-07-02 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Insulet |
| Distribution | n/a |
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.
Identifiers
| code_info | Model Number: PT-000664/M009-S-AP. UDI-DI: 10385083000336. All software versions 1.X.X |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2016-2025%22
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