---
title: "Z-800 Infusion System. Model/Catalog Number: Z-800, Z-800F, Z-800W, Z-800WF. ... — FDA record Z-0506-2025 | Is It on Recall"
description: "Potential for the battery to deplete over time from self-discharge and internal parasitic leakage current despite being continuously plugged into AC mains."
url: https://isitonrecall.com/recall/fda-device-z-0506-2025-z-800-infusion-system-model-catalog-number-z-800-z-800f-z-800w-z-800wf-the-z-800-infusion-system-is/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# Z-800 Infusion System. Model/Catalog Number: Z-800, Z-800F, Z-800W, Z-800WF. The Z-800 Infusion system is intended to... — FDA record Z-0506-2025

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Oct 18, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **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**: Potential for the battery to deplete over time from self-discharge and internal parasitic leakage current despite being continuously plugged into AC mains.
- **Classification**: Class II
- **Recalling firm**: Zyno Medical LLC
- **Quantity**: 34,994 units
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-0506-2025

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0506-2025%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | Model/Catalog Number: Z-800, Z-800F, Z-800W, Z-800WF Lot Code: Lots: 201016280, 200515888, 200406416, 230920212, 200413400, 20040660, 200716968, 201016720, 20071632, 201211740, 201208256, 210319640, 210709900, 201211360, 2101221000, 210913560, 210913200, 231008352, 220205400, 220204548, 2211141000, 230206980, 230620800, 230420548, 230420136, 230525452, 230620200. |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

This product is distributed only in the United States.

No US distribution state could be established from this record. Check the official notice.

## Dates in the source

- **Report date**: Nov 27, 2024
- **Recall initiation date**: Oct 18, 2024
- **Center classification date**: Nov 21, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0506-2025%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Zyno Medical LLC records](https://isitonrecall.com/brand/zyno-medical-llc/)