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Tandem Diabetes Care, Inc. recalls t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobile app)
Recalled October 1, 2025 · FDA recall Z-2621-2025 · Tandem Diabetes Care
Hazard
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. · FDA Class II
Units
19
Sold at
International distribution to the country of Israel.
Description
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.
Product
t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobile app)
Manufacturer(s)
Tandem Diabetes Care, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →