Tandem Diabetes Care, Inc. recalls t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobile app)

Recall date

July 3, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2621-2025

FDA classification

Class II

Brand / firm

Tandem Diabetes Care, Inc.

Sold / distributed

International distribution to the country of Israel.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobile app)