Tandem Diabetes Care Recalls

3 recalls found for Tandem Diabetes Care. Check if any of your products are affected.

Health & Personal Care
HIGH
FDA DEVICE

Tandem Diabetes Care Insulin Infusion Pumps Recalled 1,380 Units in 2026 Over Czech Guide Error

Tandem Diabetes Care recalled 1,380 insulin infusion pumps distributed internationally in the Czech Republic and Slovakia after translation errors in the Czech user guide could cause unintended insulin delivery. The most significant error told users to verify the infusion set is connected to the body when it should be confirming it is not connected. Following this instruction could result in a hyp

Tandem Diabetes Care
The Czech
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Health & Personal Care
HIGH
FDA DEVICE

Tandem Diabetes Care Recalls 122,958 t:slim X2 and Tandem Mobi Pumps Over Autobolus Risk (2025)

Tandem Diabetes Care recalled 122,958 insulin pumps nationwide in the United States, including Puerto Rico. A software defect in versions 7.9.0.1 and 7.10.1 for the t:slim X2 and version 7.9.0.1 for the Tandem Mobi paired with a Dexcom G7 sensor can trigger an unexpected automatic insulin correction bolus, raising the risk of hypoglycemia. Users should stop using the affected devices and follow a)

Tandem Diabetes Care
A software
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Health & Personal Care
HIGH
FDA DEVICE

Tandem Diabetes Care Recalling 19 Units of t:slim X2 Insulin Pump Over RTL App Defect (2025)

Tandem Diabetes Care recalls 19 units of the t:slim X2 insulin pump with interoperable technology distributed internationally, including Israel. An app defect occurs when the phone uses a right-to-left language and can cause app-pump pairing problems and graphical defects. Patients should stop using the device immediately and follow the manufacturer’s recall instructions.

Tandem Diabetes Care
an app
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