Class II
Medical Device Recall: t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobile app)
Tandem Diabetes Care, Inc. · July 3, 2025
Reason for Recall
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.
Distribution
International distribution to the country of Israel.
Quantity Affected
19
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2621-2025
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.