# FDA recall Z-0232-2026

> **Tandem Diabetes Care, Inc.** · Class II · device recall initiated 2025-08-05.

## Product

t:slim X2 insulin pump with Interoperable Technology, Control-IQ+ technology, REF: 1014070, 1014071, 1014072, 1014073, and User Guide when using Dexcom G7 sensor;  Tandem Mobi insulin pump with Interoperable Technology, Control-IQ+ technology, REF: 1014801, 1014811, 1014813, and User Guide when using Dexcom G7 sensor

## Reason for recall

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 Tandem Mobi pump with Control-IQ+ technology that are paired with a G7 sensor may result in an unexpected automatic insulin correction bolus (autobolus ) which could result in hypoglycemia.

## Distribution

US nationwide distribution including Puerto Rico.

## Key facts

- **Recall number:** Z-0232-2026
- **Recalling firm:** Tandem Diabetes Care, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-08-05
- **Report date:** 2025-10-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Diego, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0232-2026

## Citation

> AI Analytics. FDA recall Z-0232-2026. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/Z-0232-2026. Source: US FDA. Licensed CC0.

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