FDA recall record · openFDA

Tandem Diabetes Care, Inc.

8 FDA recalls on record (2024–2026) — 8 device. 8 still ongoing.

Class I (most serious)

Class II

Class III

ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

A software defect in Version 7.9 of the pump software for Tandem t:slim X2 and Tandem Mobi pumps, when used with Control 2

an app defect that occurs when the phone is set to a right-to-left language, which causes app-pump pairing issues and 1

Insulin pumps manufactured with speakers from Revision A and B may malfunction ("Malfunction 16") which prevents audible 1

A software defect in versions 7.9.0.1 and 7.10.1 of the pump software for Tandem t:slim X2 and version 7.9.0.1 of the Ta 1

The Czech language user guide contained multiple translation errors. The most significant error was that it incorrectly 1

Recalls

t:slim X2 Insulin Pump with Interoperable Technology Class I 2025-02-27 Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF: 1000911; t:slim X2 GS Classic, Replacemen Class I 2025-07-21 Tandem Mobi Insulin Pump with Interoperable Technology Class I 2025-02-27 Tandem Mobi Insulin Pump: Description/Catalog: Tandem insulin pumps are battery-operated infusion pumps capable of both Class I 2025-10-06 t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology Class I 2024-03-05 Tandem pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize Class II 2026-01-30 t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobile app) Class II 2025-07-03 t:slim X2 insulin pump with Interoperable Technology, Control-IQ+ technology, REF: 1014070, 1014071, 1014072, 1014073, a Class II 2025-08-05

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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