Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Z-800 Infusion System. Model/Catalog Number: Z-800 Recalled by Zyno Medical LLC Due to Potential for the battery to deplete over time...

Date: October 18, 2024
Company: Zyno Medical LLC
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Zyno Medical LLC directly.

Affected Products

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.

Quantity: 34,994 units

Why Was This Recalled?

Potential for the battery to deplete over time from self-discharge and internal parasitic leakage current despite being continuously plugged into AC mains.

Where Was This Sold?

This product is distributed only in the United States.

About Zyno Medical LLC

Zyno Medical LLC has 16 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report