The US Food and Drug Administration (FDA) has posted a Class II recall for certain versions of the Tandem Mobi mobile app on Android. A software problem can cause the app to omit the immediate part of an extended insulin bolus without a separate alert. That can leave a person with less insulin than intended and lead to high blood glucose.
Tandem’s instructions, as published by the FDA, tell affected Android users not to use Extended Bolus. The notice says that Standard Bolus and other available app functions can still be used. It is not an instruction to stop using the insulin pump.
Which Tandem Mobi users are affected?
The FDA lists the Tandem Mobi insulin pump with the Android Tandem Mobi mobile app, model 1015472. The listed Android app versions are 3.5.4, 3.5.2.2 and 3.5.2.1. These are app versions, not versions of the Android operating system.
The FDA record lists US nationwide distribution and the Czech Republic. It lists 4,086 users under quantity in commerce. That is not a count of people who experienced the problem or were harmed. The record does not give an injury count or show how often the fault occurred.
Check the exact app name and version rather than relying on the pump name alone. The recall record is specific to Android and does not list the iPhone app. That does not rule out separate notices for the same pump or other devices.
What can happen with Extended Bolus?
An extended bolus can split a dose into two parts: insulin delivered straight away and insulin delivered over time. With the fault described by the FDA, the later part is delivered, but the immediate part can be missed. Seeing the later delivery does not mean the full intended bolus was delivered.
The app does not give a separate alert for the missed immediate portion. The safety concern is therefore not just that the insulin dose may be smaller than intended, but that the person using the pump or their caregiver may not realise it.
What should affected users do?
Follow the instructions in Tandem’s notice. Share it with anyone else who helps manage the pump and acknowledge receipt using the link or QR code in the original notice. Contact Tandem if you cannot confirm the app version, did not receive the notice or are unsure what applies to your device. The FDA record does not specify a replacement app version.
Speak to your diabetes care team if you rely on Extended Bolus and are unsure how to manage meals while the feature is unavailable to you. Do not assume that switching bolus types means you should take the same insulin all at once, and do not repeat a dose based on this article. Follow your established care plan and seek medical help if you are unwell or cannot manage high glucose as directed in that plan.
Is this the same as the Tandem Mobi occlusion recall?
No. The FDA posted this Android app entry on 12 November 2026, following Tandem’s 13 October device correction. The FDA lists the recall as open. A separate FDA record deals with false occlusion alarms on some Tandem Mobi pumps. That is a different problem with its own instructions. Match any notice you receive to its device details and recall number before acting on it.
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