Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1868-2025 — Z-800WF Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.

U.S. FDA — Device Enforcement · United States · 2025-05-07 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1868-2025
Date of alert
2025-05-07
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Zyno Medical LLC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00814371020037
Reported risk: Unreleased software versions were installed on distributed devices without verification or validation.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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