# FDA recall Z-2621-2025

> **Tandem Diabetes Care, Inc.** · Class II · device recall initiated 2025-07-03.

## Product

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

## 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.

## Key facts

- **Recall number:** Z-2621-2025
- **Recalling firm:** Tandem Diabetes Care, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-07-03
- **Report date:** 2025-10-01

- **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-2621-2025

## Citation

> AI Analytics. FDA recall Z-2621-2025. Retrieved 2026-09-15 from https://api.ai-analytics.org/recall/Z-2621-2025. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*