Tandem T:Slim Mobile Application
The t:slim iOS app has a software issue preventing pairing with CGM sensors, which could lead to hypoglycemia or hyperglycemia.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
Tandem Diabetes Care, Inc. began a recall on July 16, 2026, of the t:slim Mobile Application, iOS software version 2.13, after a beta version had a software issue preventing pairing with Abbott FreeStyle Libre 3 Plus CGM sensors, requiring manual mode use.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI matches.
Tandem t:slim mobile application t:slim Mobile Application, iOS
- UDI-DI
- 00389152470641
- Model/Catalog number
- iOS software version 2.13
- Software version
- iOS software version 2.13
- UDI
- 00389152470740 Component: No
Details
- Company began the recall
- Sold in
US Nationwide distribution.
- Event ID
- 99589
- Recall No.
- Z-3330-2026
- Company
- Tandem Diabetes Care, Inc.San Diego, California
- Hazard
- Software defect
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
Summary updated
In FDA's weekly enforcement report
