FDA Recall: Unreleased software versions were installed on distributed devices without verification or validation

Company: Zyno Medical LLC
Date of Enforcement Report: 6/6/2025
Class: I

PRODUCT

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

Recall Number:

REASON:

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

RECALLING FIRM/MANUFACTURER:

Zyno Medical LLC

VOLUME:

613 units

DISTRIBUTION:

US Nationwide