# FDA recall Z-1253-2025

> **Baxter Healthcare Corporation** · Class I · device recall initiated 2025-02-05.

## Product

Baxter Sigma Spectrum Infusion System (V6 Platform), Product Code 35700BAX

## Reason for recall

There is the potential for missing motor mounting screws, which may have occurred during the servicing process.

## Distribution

US:  Nationwide

## Key facts

- **Recall number:** Z-1253-2025
- **Recalling firm:** Baxter Healthcare Corporation
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-02-05
- **Report date:** 2025-03-12

- **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-1253-2025

## Citation

> AI Analytics. FDA recall Z-1253-2025. Retrieved 2026-07-12 from https://api.ai-analytics.org/recall/Z-1253-2025. Source: US FDA. Licensed CC0.

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