t:slim X2 Insulin Pump (Tandem) – App Pairing Issue (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobile app)
Brand
Tandem Diabetes Care, Inc.
Lot Codes / Batch Numbers
Tandem t:slim Mobile App
Products Sold
Tandem t:slim Mobile App, Android Software Version 2.9.1 UDI-DI code: 00389152470641 Serial Numbers / Cell Phone OS: 1163923 Google Pixel 8 Pro husky [15 35] 1164430 samsung SM-S901E r0qxxx [15 35] 1167131 samsung SM-A346E a34xdxx [14 34] 1299238 samsung SM-G780G r8qxx [13 33] 1300180 samsung SM-S928B e3qxxx [15 35] 1300180 samsung SM-S928B e3qxxx [14 34] 1329242 Google Pixel 6 Pro raven [15 35] 1381313 samsung SM-G780G r8qxx [13 33] 1381315 Google Pixel 9 tokay [16 36] 1381537 samsung SM-A546E a54xnsxx [14 34] 1381570 Xiaomi 2407FPN8EG rothko_global [15 35] 1391808 samsung SM-S711B r11sxxx [14 34] 1391892 samsung SM-N980F c1sxx [13 33] 1392863 samsung SM-S926B e2sxxx [15 35] 1392953 samsung SM-S916B dm2qxxx [15 35] 1393040 samsung SM-S901E r0qxxx [15 35] 90615975 realme RMX3241 RMX3241 [13 33] 90754587 samsung SM-S916B dm2qxxx [15 35] 901144584 samsung SM-S901E r0qxxx [14 34]
Tandem Diabetes Care, Inc. is recalling t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobile app) due to an app defect that occurs when the phone is set to a right-to-left language, which causes app-pump pairing issues and graphical defects, which can pot. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
an app defect that occurs when the phone is set to a right-to-left language, which causes app-pump pairing issues and graphical defects, which can potentially lead to incorrect therapy decisions and subsequent hypoglycemia or hyperglycemia.
Recommended Action
Per FDA guidance
On 07/03/2025, the firm sent an "URGENT FIELD SAFETY NOTICE" it distributor to notify customers that users operating an Android phone with language setting set as Hebrew may experience a blank screen on the mobile application during the initial pairing sequence. The language setting must be set to English for the pairing sequence to work successfully. However, if users set their language back to a right-to-left language after pairing, or do not encounter the initial issue, the mobile application will display discrepancies. This discrepancy may cause a user to make incorrect therapy decisions that may result in under-delivery or over-delivery of insulin. Customers are instructed to: If you are operating the Tandem t:slim mobile app version 2.9.1 on an Android smartphone, and your device language is set to a right-to-left language, please revert your phone language setting to English. You can do this by navigating to the Settings app on your device. If you are unable to or do not want to change your phone language to English, Tandem recommends not to use the Android Tandem t:slim mobile app version 2.9.1 until a future update addresses this issue. Additional Recommended Best Practices: 1. Continue using your Tandem pump as described in the User Guide. 2. Regularly check your blood sugar to ensure you are not having unexpectedly high or low readings. 3. Pay attention to all system alerts and alarms. 4. Always carry back-up supplies. For questions or assistance - Additional information of this Field Safety Notice is available by contacting Padagis at Inbal.hadasheli@padagis.com.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026