Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death. Distribution is nationwide and the recall remains in progress.
Device
Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
Unreleased software versions were installed on distributed devices without verification or validation.
Recall record
Recall number
Z-1865-2025
Classification
Class I
Status
Ongoing
Voluntary or mandated
Voluntary: Firm initiated
Firm notification
E-Mail
Distribution
US Nationwide
Recall initiated
2025-05-07
Classified by FDA Center
2025-06-06
FDA published
2025-06-18
Recalling firm
Zyno Medical LLC
Firm location
Natick, MA
Operational response
A Class I device recall indicates a strong likelihood of serious adverse
health consequence or death from continued use. Identify affected units
by serial number, lot, or GTIN against your inventory and against
implanted-device patient registry. Pull affected inventory from active
use immediately. For implanted devices, follow the recalling firm’s
patient-notification protocol; in most cases this requires informing
affected patients and their treating physicians directly.