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

Recall Z-0506-2025 — Z-800 Infusion System. Model/Catalog Number: Z-800, Z-800F, Z-800W, Z-800WF. The Z-800 Infusion system is intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient under the direction or supervision of a physician or other certified healthcare profess

U.S. FDA — Device Enforcement · United States · 2024-10-18 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0506-2025
Date of alert
2024-10-18
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Zyno Medical LLC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
201016280
Reported risk: Potential for the battery to deplete over time from self-discharge and internal parasitic leakage current despite being continuously plugged into AC mains.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.