# FDA recall Z-2095-2025

> **Baxter Healthcare Corporation** · Class I · device recall initiated 2025-06-20.

## Product

Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAX

## Reason for recall

Certain Spectrum infusion pumps may have an incorrect version of software.

## Distribution

US States: CA, FL, IL, KS, MI, MS, NY, OH, OK, and VA.

## Key facts

- **Recall number:** Z-2095-2025
- **Recalling firm:** Baxter Healthcare Corporation
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-06-20
- **Report date:** 2025-07-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Deerfield, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2095-2025

## Citation

> AI Analytics. FDA recall Z-2095-2025. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2095-2025. Source: US FDA. Licensed CC0.

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