The Recall Desk
HighFDA (Devices)·Z-2621-2025·Announced 2025-10-01

Insulin pump app recalled over defect in right-to-left language settings

The t:slim X2 Insulin Pump with the Tandem t:slim mobile app is recalled because an app defect in right-to-left language settings causes pairing and graphical faults that could lead to incorrect therapy decisions.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; the notice describes potential incorrect therapy decisions leading to hypoglycemia or hyperglycemia, with no injuries reported.

Plain-English summary

The t:slim X2 Insulin Pump with Interoperable Technology, used with the Tandem t:slim mobile app, Android software version 2.9.1, UDI-DI 00389152470641, is being recalled. The recall covers 19 units distributed internationally in Israel.

The recall was issued because of an app defect that occurs when the phone is set to a right-to-left language, causing app-pump pairing issues and graphical defects. The manufacturer states this can potentially lead to incorrect therapy decisions and subsequent hypoglycemia or hyperglycemia. The FDA classified the action as Class II.

Users should follow the manufacturer's instructions for updating the app and should contact their clinician about any therapy decision they are unsure of.

The recalled product

Product
t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobile app)
Manufacturer
Tandem Diabetes Care, Inc.
Category
Medical Device — Insulin Pump
Hazard
  • software-defect
  • app-pairing
  • insulin-dosing
  • class-ii

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Tandem t:slim Mobile App

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category