Drugs & medicalClass II

Tandem Diabetes Care Inc recalls t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM, and t:slim X2 Insulin Pump with Basal-IQ Technology

Insulin pumps may display unexpected fluctuation of the remaining battery life so ensure pump battery life does not fall below 25% remaining power. If the battery life drops to less than 5%, insulin delivery will…

Read the official notice →
Date
2022-06-22
Country
United States
Brand
Tandem Diabetes Care
Product
t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM, and t:slim X2 Insulin Pump with Basal-IQ Technology
Classification
Class II
Units
International distribution in the country of Australia.
Category
Drugs & medical
Source
FDA · Device

Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer

What to do

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. Ask the pharmacy or supplier about a replacement or refund.

General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.

More Tandem Diabetes Care recalls

  1. 2025-10-29
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    Tandem Diabetes Care, Inc. recalls t:slim X2 insulin pump with Interoperable Technology, Control-IQ+ technology, REF: 1014070, 1014071, 1014072, 1014073, and User Guide…

    A software defect in versions 7.9.0.1 and 7.10.1 of the pump software for Tandem t:slim X2 and version 7.9.0.1 of the Tandem Mobi pump with Control-IQ+ technology that are paired with a G7 sensor may result in an…

    FDA · DeviceTandem Diabetes Care, Inc.US nationwide distribution including Puerto Rico.Official notice →
  3. 2025-10-01
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    Tandem Diabetes Care, Inc. recalls t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim 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…

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  5. 2025-09-03
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    Tandem Diabetes Care, Inc. recalls Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF: 1000911; t:slim X2 GS Classic, Replacement, Refurbished,…

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  7. 2025-04-23
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    A software defect in Version 7.9 of the pump software for Tandem t:slim X2 and Tandem Mobi pumps, when used with Control IQ+ technology, will cause the pump to incorrectly interpolate glucose trends when the Estimated…

    FDA · DeviceTandem Diabetes Care, Inc.US: AZ, CA, CO, CT, FL, HI, IA, ID, IL, IN, MD, ME, MI, MO, MS, NC, ND, NE,…Official notice →
  9. 2024-05-15
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    Tandem Diabetes Care, Inc. recalls t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology

    During normal use, the mobile app version 2.7 may crash and be automatically relaunched by the iOS operating system. This cycle intermittently repeats, which leads to excessive Bluetooth communication that may result…

    FDA · DeviceTandem Diabetes Care, Inc.US nationwide distribution including Puerto Rico.Official notice →
  11. 2022-10-05
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    Tandem Diabetes Care Inc recalls t:slim X2 insulin pump; t:slim X2 insulin pump with Dexcom G5; t:slim X2 insulin pump with Basal-IQ technology; t: slim x2 insulin pump…

    Insulin pumps may have the following issues: 1) Malfunction 6 Non-Volatile Memory, 2) Inaccurate (Fluctuating) Battery Life Display, 3) Touchscreen Staying On, 4) Unexpected Open Loop, that can be mitigated with a…

    FDA · DeviceTandem Diabetes Care IncUS: NC, OK, ME, NY, TX, LA, NE, FL, AZ, IL, OH, CA, AL, MI, UT, VA, MA, SC,…Official notice →
All 10 Tandem Diabetes Care recalls →

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