---
title: "t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobi... — FDA record Z-2621-2025 | Is It on Recall"
description: "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 l"
url: https://isitonrecall.com/recall/fda-device-z-2621-2025-t-slim-x2-insulin-pump-with-interoperable-technology-with-tandem-t-slim-mobile-app/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobile app) — FDA record Z-2621-2025

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Jul 3, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobile app)
- **Reason**: 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.
- **Classification**: Class II
- **Recalling firm**: Tandem Diabetes Care, Inc.
- **Quantity**: 19
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-2621-2025

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2621-2025%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | 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] |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

International distribution to the country of Israel.

No US distribution state could be established from this record. Check the official notice.

## Dates in the source

- **Report date**: Oct 1, 2025
- **Recall initiation date**: Jul 3, 2025
- **Center classification date**: Sep 24, 2025

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2621-2025%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Tandem Diabetes Care Inc records](https://isitonrecall.com/brand/tandem-diabetes-care-inc/)