Z-2621-2025Class II

t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobile app)

Name: Z-2621-2025 t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobile app)
Creator: Tandem Diabetes Care, Inc.
Published: 2025-07-03
License: https://open.fda.gov/license/

Tandem Diabetes Care, Inc. / initiated 2025-07-03 / Open, Classified / root cause: software

FDA source

Tandem Diabetes Care, Inc. began a recall of t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobile app) on 2025-07-03. FDA classified it as Class II and gives the reason as "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...". 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-2621-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-07-03
Posted: 2025-09-24
Recalling firm: Tandem Diabetes Care, Inc.
Product: t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobile app)
Product code: QFG Alternate Controller Enabled Insulin Infusion Pump
Reason for recall: 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.
Root cause tag: software
FDA root cause: Software design
Action: 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 [email protected].
Quantity in commerce: 19
Distribution: International distribution to the country of Israel.
Product codes and lots: 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]

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2621-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2621-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-10-01	2025-09-24

Product code QFG

K232380Class IIt:slim X2 Insulin Pump with Interoperable TechnologyTandem Diabetes Care, Inc. / cleared 2023-11-03

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)