# FDA recall Z-1183-2024

> **Zyno Medical LLC** · Class II · device recall initiated 2023-12-20.

## Product

Zyno Medical Z800 Large Volume Infusion Pumps -Intended to provide intravenous infusion of parenteral fluids, blood and blood products to a patient under the direction or supervision of physician or other certified health care professional  Model: Z-800WF

## Reason for recall

When utlizing the patient query feature on the Zyno Medical Z-800WF pumps with software version 5.2.05, the alarm volume may inadvertently revert from a higher volume setting to a low one, causing potential delays in therapy and in extreme cases, associated risk of organ failure or death

## Distribution

Nationwide

## Key facts

- **Recall number:** Z-1183-2024
- **Recalling firm:** Zyno Medical LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-12-20
- **Report date:** 2024-03-06

- **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-1183-2024

## Citation

> AI Analytics. FDA recall Z-1183-2024. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1183-2024. Source: US FDA. Licensed CC0.

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