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

Tandem t:slim X2 Insulin Pump app defect may cause therapy errors

The Tandem t:slim X2 insulin pump app may fail to communicate properly on right-to-left language phones, potentially causing incorrect insulin doses and blood sugar problems.

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: This is an FDA Class II recall with no reported injuries or illnesses. However, the app defect affects critical insulin delivery communications, and the source identifies potential for incorrect therapy decisions leading to blood sugar abnormalities—a risk-of-harm product scenario per the severity rubric.

Plain-English summary

The FDA is recalling 19 Tandem t:slim X2 Insulin Pumps distributed to Israel due to a software defect in the mobile app.

The defect occurs when a user's phone is configured with a right-to-left language setting. This causes the app to malfunction in communicating with the insulin pump, including pairing failures and display errors. The app-pump communication failures can lead to incorrect therapy decisions and potential blood sugar abnormalities including hypoglycemia (low blood sugar) and hyperglycemia (high blood sugar).

Users with affected devices should contact Tandem Diabetes Care immediately for guidance. Patients should not ignore any unusual pump or app behavior and should monitor blood sugar levels closely. If experiencing symptoms of low or high blood sugar, seek immediate medical attention.

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 / Infusion System
Hazard
  • app-malfunction
  • device-pairing-failure
  • insulin-dosing-error

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.

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