Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

TherMax Blood Warmer Unit-US Recalled by VANTIVE US HEALTHCARE LLC Due to Thermax System may be unable to detect the...

Date: July 28, 2025
Company: VANTIVE US HEALTHCARE LLC
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact VANTIVE US HEALTHCARE LLC directly.

Affected Products

TherMax Blood Warmer Unit-US, PrisMax Accessory, Product Codes: 955630, 955515, 955702, 955631

Quantity: 7432 units

Why Was This Recalled?

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

Where Was This Sold?

Worldwide

About VANTIVE US HEALTHCARE LLC

VANTIVE US HEALTHCARE LLC has 11 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report