# FDA recall Z-2439-2025

> **VANTIVE US HEALTHCARE LLC** · Class II · device recall initiated 2025-07-28.

## Product

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

## Reason for recall

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

## Distribution

Worldwide

## Key facts

- **Recall number:** Z-2439-2025
- **Recalling firm:** VANTIVE US HEALTHCARE LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-07-28
- **Report date:** 2025-09-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Deerfield, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2439-2025

## Citation

> AI Analytics. FDA recall Z-2439-2025. Retrieved 2026-08-18 from https://api.ai-analytics.org/recall/Z-2439-2025. Source: US FDA. Licensed CC0.

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