Class II — Potential Health Hazard

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

Zyno Medical Z800 Large Volume Infusion Pumps -Intended to provide Recalled by Zyno Medical LLC Due to When utlizing the patient query feature on the...

Date: December 20, 2023
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

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

Quantity: 574 units

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

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