Class II U.S. Food and Drug Administration

Tandem Diabetes Care, Inc. t:slim X2 Insulin Pump with Interoperable Technology recall: an app defect that occurs when the phone is set to a right-to-left language

Recall published 1+ years ago

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.

The hazard: Device safety concern

The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

What the notice says: 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.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-2621-2025
Published
October 1, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Tandem Diabetes Care, Inc.
Product type
Medical devices
Units affected
19
Made in
United States
Lot / code info
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]
UPC codes
00389152470641

Products covered by this recall

t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobile app)

Check your product

The notice names 2 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 00389152470641

Serial number

On the rating plate, often next to the date of manufacture.

  • Cell Phone OS

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Tandem Diabetes Care, Inc. — The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  3. Ask the supplier or clinic that provided it what the remedy is in your case.
  4. If you are a facility, quarantine affected stock and log the correction.

Who pays for a device recall

The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.

  • If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
  • Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
  • If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
  • Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.

Company contact: Tandem Diabetes Care, Inc. — 12400 High Bluff Dr, San Diego, CA, 92130-3077

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Tandem Diabetes Care, Inc. medical devices recalled?

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. 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.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00389152470641. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.

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