# FDA recall Z-1121-2026

> **Baxter Healthcare Corporation** · Class II · device recall initiated 2025-11-28.

## Product

SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2

## Reason for recall

Certain pumps have potentially been released from service with defective grease applied to the cam and motor gears. Due to its low viscosity, the defective grease may lead to the device having insufficient lubrication on the cam, which could lead to premature wear of the mechanism assembly, resulting in over-infusion or a free-flow situation.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-1121-2026
- **Recalling firm:** Baxter Healthcare Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-11-28
- **Report date:** 2026-01-28

- **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-1121-2026

## Citation

> AI Analytics. FDA recall Z-1121-2026. Retrieved 2026-07-13 from https://api.ai-analytics.org/recall/Z-1121-2026. Source: US FDA. Licensed CC0.

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