# FDA recall Z-1865-2025

> **Zyno Medical LLC** · Class I · device recall initiated 2025-05-07.

## Product

Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.

## Reason for recall

Unreleased software versions were installed on distributed devices without verification or validation.

## Distribution

US Nationwide

## Key facts

- **Recall number:** Z-1865-2025
- **Recalling firm:** Zyno Medical LLC
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-05-07
- **Report date:** 2025-06-18

- **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-1865-2025

## Citation

> AI Analytics. FDA recall Z-1865-2025. Retrieved 2026-07-16 from https://api.ai-analytics.org/recall/Z-1865-2025. Source: US FDA. Licensed CC0.

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