Tandem Mobi Android app recalled for possible insulin underdelivery
A software defect in the Tandem Mobi Android app can reduce the immediate portion of an extended bolus to 0 units when the entered glucose value equals the user's active target glucose. The total insulin delivered may be less than intended, and the app does not give a separate alert when the immediate portion is omitted. This could lead to unrecognized under-delivery of insulin and high blood sugar.
From the FDA notice · Read the official notice ↗ · All Tandem Diabetes Care recalls
What to do
- Contact your care team and Tandem Diabetes Care before changing your insulin pump therapy; do not stop the pump on your own.
- Check whether you use the Tandem Mobi Android app, versions 3.5.4, 3.5.2.2, or 3.5.2.1 (UDI-DI 00389152547244).
- The notice does not say how to get a fix or update; contact Tandem Diabetes Care for instructions.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Tandem Mobi Insulin Pump with Interoperable Technology (with Android Tandem Mobi Mobile app) Model/Catalog Number: 1015472
- Sold in
- Nationwide
- Made for
- Adults (0 months and older)
Details
- Units affected
- 4086 users
- Illnesses reported
- None reported
- Manufactured in
- 12400 High Bluff Dr, San Diego, California, United States
- Classification
- Class II
- Recall number
- Z-0437-2027
In the FDA's words
- Description
- Tandem Mobi Insulin Pump with Interoperable Technology (with Android Tandem Mobi Mobile app) Model/Catalog Number: 1015472 A software defect in the Tandem Mobi mobile application for Android (versions 3.5.4, 3.5.2.2, and 3.5.2.1) in which the immediate ( Now ) portion of an Extended Bolus is incorrectly reduced to 0 units when the entered glucose value equals the user s active target glucose value; the deferred ( Later ) portion is delivered, but the total insulin delivered may be less than intended, and the application does not provide a distinct alert that the immediate portion was omitted, potentially resulting in unrecognized under-delivery of insulin and hyperglycemia. Lot Code: UDI-DI: 00389152547244 Software versions: 3.5.4, 3.5.2.2, and 3.5.2.1 Distribution: Worldwide - US Nationwide and the country of Czech Republic. Affected quantity: 4086 users
- Hazard
- A software defect in the Tandem Mobi mobile application for Android (versions 3.5.4, 3.5.2.2, and 3.5.2.1) in which the immediate ( Now ) portion of an Extended Bolus is incorrectly reduced to 0 units when the entered glucose value equals the user s active target glucose value; the deferred ( Later ) portion is delivered, but the total insulin delivered may be less than intended, and the application does not provide a distinct alert that the immediate portion was omitted, potentially resulting in unrecognized under-delivery of insulin and hyperglycemia.
More from Tandem Diabetes Care
See all- Tandem Mobi insulin pumps recalled for false occlusion alarms
SeriousFDAOct 30, 2026
- Tandem t:slim iOS app 2.13 recalled for CGM pairing failure
ModerateFDAOct 7, 2026