# FDA recall Z-0523-2025

> **Zyno Medical LLC** · Class III · device recall initiated 2024-09-30.

## Product

Brand Name: Z-800 Infusion System  Product Name: Z-800WF  Model/Catalog Number: 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 physician or other certified healthcare professional.

## Reason for recall

For the Z-800WF pumps, the WiFi software was not compatible with the pump software that had been loaded in accordance with ongoing correction Z-1183-2024.

## Distribution

Domestic: AL, FL, LA, MI, NE, NJ, OH, TX.

## Key facts

- **Recall number:** Z-0523-2025
- **Recalling firm:** Zyno Medical LLC
- **Classification:** Class III
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-09-30
- **Report date:** 2024-12-04

- **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-0523-2025

## Citation

> AI Analytics. FDA recall Z-0523-2025. Retrieved 2026-08-03 from https://api.ai-analytics.org/recall/Z-0523-2025. Source: US FDA. Licensed CC0.

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