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

Recall Z-2439-2025 — TherMax Blood Warmer Unit-US, PrisMax Accessory, Product Codes: 955630, 955515, 955702, 955631

U.S. FDA — Device Enforcement · United States · 2025-07-28 · Class II

AI-assisted, human-edited — this page is drafted with AI from public-source data, then reviewed before publication. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2439-2025
Date of alert
2025-07-28
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
VANTIVE US HEALTHCARE LLC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
07332414124731
Reported risk: Thermax System may be unable to detect the presence of a bag on the Thermax Blood Warmer Unit leading to difficulty setting up therapy, or PrisMax System alarm T2284: Thermax Disposable Not Inserted
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.

Related

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.