Omnipod 5 Automated Insulin Delivery System, iOS… recallZ-2016-2025 · Insulet Corporation · initiated May 23, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Insulet Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Software design
What the company is doing
Insulet notified health care professionals and users on 05/23/2025 via emailed letter. Consignees were instructed to make sure your phone s keyboard and region settings match the approved country for use currently, the U.S. only and this issue does not affect the Insulet-provided Omnipod 5 Controllers or the Omnipod 5 App on compatible Android phones. A software update will be pushed to all devices in the coming weeks, and each consignee will be notified via email and in-app notification on the device when it is ready to install. The fix will allow commas to be recognized as decimal points when using the Omnipod 5 App for iPhone. The email notification to users included a section to formally acknowledge the notification.
Recall details
- Recall number
- Z-2016-2025
- Status
- Open, Classified
- Initiated by the company
- May 23, 2025
- Posted by the FDA
- Jun 24, 2025
- Recalling firm
- Insulet Corporation
- Quantity
- 122,823 downloads
- Product code
- QRX
- FDA submissions
- K231826
- Distribution
- US market only- Although there are 122823 downloads of the application, our data shows there are only ~80k active users.
Product description
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.
Code information (models, lots, serial numbers)
Model Number: PT-000664/M009-S-AP. UDI-DI: 10385083000336. All software versions 1.X.X
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Omnipod 5 Controller APP M009-S-APInsulet Corporation · Continuous Glucose Monitor Informed Insulin Dose Calculator1 recall15 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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