# FDA recall Z-2343-2025

> **Tandem Diabetes Care, Inc.** · Class I · device recall initiated 2025-07-21.

## Product

Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF: 1000911;  t:slim X2 GS Classic, Replacement, Refurbished, REF: 1003808;  t: slim X2, Basal-IQ, mg/dl, REF: 1004219;  Pump, t:slim X2, Clinical Use Only, REF: 1004484;  Pump, t:slim X2, Control-IQ, REF: 1005611;  Pump, t:slim X2, Control-IQ, mmoUL, Refurbished Replacement, REF: 1005613;   Pump, t:slim X2, Control-IQ, mg/dl, REF: 1005615;  Pump, t:slim X2, Control-IQ, mg/dl, Refurbished Replacement, REF: 1005617;   Pump, t:slim X2, Basal-IQ 6.4, Refurbished Replacement, REF: 1006379;  Pump, t:slim X2, Control-IQ 7.4, REF: 1006402;  Pump, t:slim X2, Control-IQ 7.4, Replacement, REF: 1006406;   Pump, t:slim X2, Control-IQ 7.4, REF: 1006408;  Pump, t:slim X2, Basal-IQ, , REF: 1006419;  Pump, t:slim X2, Basal-IQ, mg/dL, REF: 1006420;   Pump, t:slim X2, Basal-IQ, mmoUL, Refurbished Replacement, REF: 1006535;   Pump, t:slim X2, Basal-IQ, mg/dL, Refurbished Replacement, REF: 1006537;  Pump, t:slim X2, Control-IQ, mg/d

## Reason for recall

Insulin pumps manufactured with speakers from Revision A and B may malfunction ("Malfunction 16") which prevents audible alerts and causes the pumps to become inoperable and stop infusing insulin which could result in a hyperglycemic event, which may lead to injury and/or hospitalization.

## Distribution

Worldwide distribution. US nationwide including Puerto Rico, Canada, Czech Republic, Slovakia, Spain, United Kingdom, Belgium, Luxembourg, Australia, France, Italy, New Zealand, Finland, Sweden, Denmark, Norway, Saudi Arabia, Germany, Netherlands, Ireland, Portugal, South Africa, Switzerland

## Key facts

- **Recall number:** Z-2343-2025
- **Recalling firm:** Tandem Diabetes Care, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-07-21
- **Report date:** 2025-09-03

- **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-2343-2025

## Citation

> AI Analytics. FDA recall Z-2343-2025. Retrieved 2026-09-04 from https://api.ai-analytics.org/recall/Z-2343-2025. Source: US FDA. Licensed CC0.

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