Tandem Diabetes Care, Inc. Recalls

All product recalls associated with Tandem Diabetes Care, Inc..

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Recall Summary

Total Recalls

9

Past Year

6

Class I (Serious)

0

Most Recent

Oct 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–9 of 9 recalls

Tandem Mobi Insulin Pump (Tandem) – vibration motor fault (2025)

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 operate, the mobile app can no longer receive data from the pump. Insulin delivery and any active CGM Sessions have been stopped", which could result in hyperglycemia.

Moderate

FDAOct 6, 2025AL, AK, AZ +49 more• Tandem Diabetes Care, Inc.

t:slim X2 Insulin Pump (Tandem) – software defect (2025)

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 unexpected automatic insulin correction bolus (autobolus ) which could result in hypoglycemia.

Moderate

FDAAug 5, 2025Nationwide• Tandem Diabetes Care, Inc.

t:slim X2 G5 Insulin Pump (Tandem) – Alert Malfunction (2025)

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 a hyperglycemic event, which may lead to injury and/or hospitalization.

Moderate

FDAJul 21, 2025Nationwide• Tandem Diabetes Care, Inc.

t:slim X2 Insulin Pump (Tandem) – App Pairing Issue (2025)

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.

Moderate

FDAJul 3, 2025Nationwide• Tandem Diabetes Care, Inc.

Tandem Mobi Insulin Pump (Tandem Diabetes) – Software Defect (2025)

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 Glucose Value (EGV) is above 255 mg/dL at the start or end of a gap in data collection due to a lapse in connection from a paired continuous glucose monitor (CGM) sensor, which can lead to under-delivery or over-delivery of insulin based on inaccurate result leading to severe cases of hypoglycemia or hyperglycemia.

Moderate

FDAFeb 27, 2025AZ, CA, CO +26 more• Tandem Diabetes Care, Inc.

t:slim X2 Insulin Pump (Tandem Diabetes) – Software Defect (2025)

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 Glucose Value (EGV) is above 255 mg/dL at the start or end of a gap in data collection due to a lapse in connection from a paired continuous glucose monitor (CGM) sensor, which can lead to under-delivery or over-delivery of insulin based on inaccurate result leading to severe cases of hypoglycemia or hyperglycemia.

Moderate

FDAFeb 27, 2025AZ, CA, CO +26 more• Tandem Diabetes Care, Inc.

Tandem Diabetes Care, Inc.: t:connect mobile app used in conjunction with t:slim X2 ...

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 in pump battery drain and may lead to the pump shutting down sooner than typically expected. Pump shutdown will cause insulin delivery to suspend, which could lead to an under-delivery of insulin and may result in hyperglycemia, including severe hyperglycemia.

Moderate

FDAMar 5, 2024Nationwide• Tandem Diabetes Care, Inc.

Tandem Diabetes Care Inc: t:slim X2 insulin pump; t:slim X2 insulin pump with Dexco...

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 software update. Issues could result in hypoglycemia, hyperglycemia or diabetic ketoacidosis.

Moderate

FDAMay 24, 2022AL, AK, AZ +49 more• Tandem Diabetes Care Inc

Tandem Diabetes Care Inc: t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM, and t:s...

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 continue for 30 minutes and then the pump will power off and insulin delivery will stop. If the battery reaches 1%, then insulin delivery will stop, which could lead to hyperglycemia.

Moderate

FDASep 10, 2020IN• Tandem Diabetes Care Inc

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Tandem Diabetes Care, Inc. Recalls

Recall Summary

Tandem Mobi Insulin Pump (Tandem) – vibration motor fault (2025)

t:slim X2 Insulin Pump (Tandem) – software defect (2025)

t:slim X2 G5 Insulin Pump (Tandem) – Alert Malfunction (2025)

t:slim X2 Insulin Pump (Tandem) – App Pairing Issue (2025)

Tandem Mobi Insulin Pump (Tandem Diabetes) – Software Defect (2025)

t:slim X2 Insulin Pump (Tandem Diabetes) – Software Defect (2025)

Tandem Diabetes Care, Inc.: t:connect mobile app used in conjunction with t:slim X2 ...

Tandem Diabetes Care Inc: t:slim X2 insulin pump; t:slim X2 insulin pump with Dexco...

Tandem Diabetes Care Inc: t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM, and t:s...