# FDA recall Z-0506-2025

> **Zyno Medical LLC** · Class II · device recall initiated 2024-10-18.

## Product

Z-800 Infusion System. Model/Catalog Number: Z-800, Z-800F, Z-800W, Z-800WF.      The Z-800 Infusion system is intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient under the direction or supervision of a physician or other certified healthcare professional.

## Reason for recall

Potential for the battery to deplete over time from self-discharge and internal parasitic leakage current despite being continuously plugged into AC mains.

## Distribution

This product is distributed only in the United States.

## Key facts

- **Recall number:** Z-0506-2025
- **Recalling firm:** Zyno Medical LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-10-18
- **Report date:** 2024-11-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Natick, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0506-2025

## Citation

> AI Analytics. FDA recall Z-0506-2025. Retrieved 2026-07-19 from https://api.ai-analytics.org/recall/Z-0506-2025. Source: US FDA. Licensed CC0.

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