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.
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.
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.
The app defect occurs when the phone is set to a right-to-left language, causing pairing issues and graphical errors. This can lead to incorrect insulin dosing decisions, potentially causing hypoglycemia (low blood sugar) or hyperglycemia (high blood sugar).
People using Tandem's t:slim X2 insulin pumps with the mobile app are affected. Those whose phones are set to right-to-left languages (like Hebrew, Arabic) face the highest risk of incorrect therapy decisions.
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.
Ensure your phone is set to a left-to-right language to avoid pairing issues with the Tandem t:slim mobile app.
Update the Tandem t:slim mobile app to the latest version to fix the language-related pairing defect.
The recall addresses a defect that occurs when the phone is set to a right-to-left language, causing app-pump pairing issues and graphical defects that may lead to incorrect therapy decisions.
The recall includes specific phone models like Samsung, Google Pixel, and Xiaomi devices with serial numbers listed in the notice.
No, but you should check your phone language settings and update the app to avoid incorrect therapy decisions.
We’ve drafted a message you can send Tandem to request your refund or repair — edit it as you like.
Subject: Recall Z-2621-2025 — Tandem Tandem Hello, I own a Tandem that is covered by recall Z-2621-2025 from Tandem. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.