Class I

Medical Device Recall: Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.

Zyno Medical LLC · May 7, 2025

Reason for Recall

Unreleased software versions were installed on distributed devices without verification or validation.

Distribution

US Nationwide

States Affected

NATIONWIDE

Quantity Affected

613 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1865-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.