Z-2016-2025Class II

Omnipod 5 Automated Insulin Delivery System, iOS Application. Model Number: PT-000664/M009-S-AP. Software...

Name: Z-2016-2025 Omnipod 5 Automated Insulin Delivery System, iOS Application. Model Number: PT-000664/M009-S-AP. Software...
Creator: Insulet Corporation
Published: 2025-05-23
License: https://open.fda.gov/license/

Insulet Corporation / initiated 2025-05-23 / Open, Classified / root cause: software

FDA source

Insulet Corporation began a recall of Omnipod 5 Automated Insulin Delivery System, iOS Application. Model Number: PT-000664/M009-S-AP. Software Version: all Product Description: The Omnipod 5 iOS... on 2025-05-23. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2016-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-05-23
Posted: 2025-06-24
Recalling firm: Insulet Corporation
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.
Product code: QRX Continuous Glucose Monitor Informed Insulin Dose Calculator
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.
Root cause tag: software
FDA root cause: Software design
Action: 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.
Quantity in commerce: 122,823 downloads
Distribution: US market only- Although there are 122823 downloads of the application, our data shows there are only ~80k active users.
Product codes and lots: Model Number: PT-000664/M009-S-AP. UDI-DI: 10385083000336. All software versions 1.X.X

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2016-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2016-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-07-02	2025-06-24

Product code QRX

K231826Class IIOmnipod 5 ACE PumpInsulet Corporation / cleared 2023-10-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)