Use caution Medical device recall · FDA · Published July 3, 2025

Tandem t:slim X2 Insulin Pump Recall: Language Settings Cause Incorrect Therapy Decisions

Tandem recalls t:slim X2 insulin pumps with app pairing issues when phone uses right-to-left language, risking incorrect blood sugar treatment. Affected units include specific Samsung, Pixel, and Xiaomi models sold with Tandem's mobile app.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2621-2025Medical device Tandem ›

Use caution until it’s fixed

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.

Take action

Contact the company

Recalling firmTandem Diabetes Care, Inc.12400 High Bluff Dr · San Diego, CA 92130-3077

✎ GovInfoNow plain-language explainer

Tandem is recalling t:slim X2 insulin pumps that may pair incorrectly with the mobile app when the phone is set to a right-to-left language. This could lead to incorrect blood sugar treatment, causing dangerously low or high blood sugar levels. Read more at govinfonow.com/recall/51846-tandem-t-slim-x2-insulin-pump-recall-language-settings-cause.

Source Summary by GovInfoNow · govinfonow.com/recall/51846-tandem-t-slim-x2-insulin-pump-recall-language-settings-cause · Updated August 17, 2026 · FDA enforcement record: FDA #Z-2621-2025

Cite this page

“Tandem t:slim X2 Insulin Pump Recall: Language Settings Cause Incorrect Therapy Decisions.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51846-tandem-t-slim-x2-insulin-pump-recall-language-settings-cause. Based on FDA recall #Z-2621-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2621-2025%22&limit=1).

The FDA announced on July 3, 2025, that Tandem Diabetes Care, Inc. is recalling the t:slim X2 Insulin Pump with Interoperable Technology due to an app defect causing pairing issues and graphical errors. These defects can potentially lead to incorrect therapy decisions and subsequent hypoglycemia or hyperglycemia.

How to tell if you have it

Brand: Tandem
Product: t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobile app)
Software Version: Android Software Version 2.9.1
UDI-DI code: 00389152470641
Serial Numbers: 1163923, 1164430, 1167131, 1299238, 1300180, 1329242, 1381313, 1381315, 1381537, 1381570, 1391808, 1391892, 1392863, 1392953, 1393040, 90615975, 90754587, 901144584
Affected Devices: Google Pixel 8 Pro, samsung SM-S901E, samsung SM-A346E, samsung SM-G780G, samsung SM-S928B, Google Pixel 6 Pro, Google Pixel 9, samsung SM-A546E, Xiaomi 2407FPN8EG, samsung SM-S711B, samsung SM-N980F, samsung SM-S926B, samsung SM-S916B, realme RMX3241
Quantity: 19 units
Distribution: International distribution to the country of Israel

The hazard

An app defect occurs when the phone is set to a right-to-left language, causing app-pump pairing issues and graphical defects. These errors can potentially lead to incorrect therapy decisions and subsequent hypoglycemia or hyperglycemia.

Context

GovInfoNow's records show Tandem Diabetes Care, Inc. has 10 other recalls on record since April 23, 2018. Other recent recalls of similar products include a July 16, 2026 recall of the t:slim Mobile Application for iOS pairing issues and an Oct. 6, 2025 recall of the Tandem Mobi Insulin Pump for false vibration motor failure risk. Other recent recalls of similar products include a May 27, 2026 recall of the Medtronic MiniMed 780G Insulin Pump for software error causing insulin stoppage and Feb. 13, 2026 recalls of Medtronic Paradigm and MiniMed 630G Insulin Pumps for risks of hypoglycemia or delivery errors.

How to tell if you have this one

Check if your pump has a Tandem t:slim mobile app with version 2.9.1. Look for specific serial numbers or phone models listed in the recall notice, including Samsung, Google Pixel, and Xiaomi devices.

Brand
Tandem
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check App Settings
Ensure your phone is set to a left-to-right language to avoid pairing issues with the Tandem t:slim mobile app.
Update App
Update the Tandem t:slim mobile app to the latest version to fix the language-related pairing defect.

How this recall unfolded

Recall timeline

FDA published this recall 3 months after the firm started it.

Jul 3, 2025Firm started the recall
Sep 24, 2025FDA classified it Class II
Oct 1, 2025Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/51846-tandem-t-slim-x2-insulin-pump-recall-language-settings-cause">Tandem t:slim X2 Insulin Pump Recall: Language Settings Cause Incorrect Therapy Decisions (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2621-2025 (July 3, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2621-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.