Tandem Diabetes Care Recalls

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

HIGHFDA 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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HIGHFDA DEVICE

Tandem Diabetes Care Insulin Pumps Recalled Over Hypoglycemia Risk

Tandem Diabetes Care recalled 122,958 insulin pumps on August 5, 2025. A software defect may cause unexpected insulin boluses, leading to hypoglycemia. Patients should stop using the devices immediately and follow the manufacturer's instructions.

Tandem Diabetes Care
A software
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HIGHFDA DEVICE

Tandem Diabetes Care Recalls t:slim X2 Insulin Pump Over App Issues

Tandem Diabetes Care recalled 19 t:slim X2 Insulin Pumps on July 3, 2025, due to an app defect. The defect affects devices when set to right-to-left languages, potentially causing incorrect therapy decisions. This may lead to hypoglycemia or hyperglycemia.

Tandem Diabetes Care
an app
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Brand Statistics

Total Recalls
3
Pages
1