# FDA recall Z-0005-2025

> **Zyno Medical LLC** · Class I · device recall initiated 2024-09-13.

## Product

Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF;  Software Version: Z-800 6.1.01 and 6-1.07z; Z-800F 4.1.02 and 4.1.08z; Z-800W 3.1.32 and 3.1.64z, Z-800WF 3.1.32 and 3.1.64z

## Reason for recall

There is a defect in the air-in-line software algorithm.

## Distribution

US Nationwide.

## Key facts

- **Recall number:** Z-0005-2025
- **Recalling firm:** Zyno Medical LLC
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-09-13
- **Report date:** 2024-10-16

- **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-0005-2025

## Citation

> AI Analytics. FDA recall Z-0005-2025. Retrieved 2026-09-08 from https://api.ai-analytics.org/recall/Z-0005-2025. Source: US FDA. Licensed CC0.

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