Tandem Diabetes Care recalls
10 official recalls and safety alerts involving Tandem Diabetes Care since 2022-06, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Tandem Diabetes Care or the relevant agency.
- 2026-10-07
USTandem Diabetes Care, Inc. recalls Brand Name: Tandem t:slim mobile application Product Name: t:slim Mobile Application, iOS Model/Catalog Number: iOS software version…
A beta (early-release) version of the iOS application, version 2.13 (TestFlight) had a software issue preventing successful pairing of the t:slim application with Abbott FreeStyle Libre 3 Plus (FSL3P) continuous…
- 2026-04-01
- US
Tandem Diabetes Care, Inc. recalls Tandem pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize a motor-driven…
The Czech language user guide contained multiple translation errors. The most significant error was that it incorrectly instructs users to verify that the infusion set is connected to the body, when it should instead…
FDA · DeviceTandem Diabetes Care, Inc.International distribution in the countries of Czech Republic, Slovakia.Official notice → - 2025-11-12
- US
Tandem Diabetes Care, Inc. recalls Tandem Mobi Insulin Pump: Description/Catalog: Tandem insulin pumps are battery-operated infusion pumps capable of both basal and…
Insulin pump includes a vibration motor that gives tactile feedback for any alerts, alarms, or malfunctions. Pump may exhibit false vibration motor failure due to a software issue causing Malfunction 12: "Pump cannot…
FDA · DeviceTandem Diabetes Care, Inc.US: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY,…Official notice → - 2025-10-29
- US
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 → - 2025-10-01
- US
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…
FDA · DeviceTandem Diabetes Care, Inc.International distribution to the country of Israel.Official notice → - 2025-09-03
- US
Tandem Diabetes Care, Inc. recalls Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF: 1000911; t:slim X2 GS Classic, Replacement, Refurbished,…
Insulin pumps manufactured with speakers from Revision A and B may malfunction ("Malfunction 16") which prevents audible alerts and causes the pumps to become inoperable and stop infusing insulin which could result in…
FDA · DeviceTandem Diabetes Care, Inc.Worldwide distribution. US nationwide including Puerto Rico, Canada, Czech…Official notice → - 2025-04-23
- US
Tandem Diabetes Care, Inc. recalls t:slim X2 Insulin Pump with Interoperable Technology
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 → - 2024-05-15
- US
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 → - 2022-10-05
- US
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 → - 2022-06-22
- US
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…
FDA · DeviceTandem Diabetes Care IncInternational distribution in the country of Australia.Official notice →