---
title: "PrisMax V2-US, Hemodialysis Delivery System, Product Codes: 955626, 955558, 9... — FDA record Z-2437-2025 | Is It on Recall"
description: "Low deaeration chamber level at post priming tests may lead to PrisMax System alarm T2309: Air Detected in Prime resulting in multiple additional priming cycles"
url: https://isitonrecall.com/recall/fda-device-z-2437-2025-prismax-v2-us-hemodialysis-delivery-system-product-codes-955626-955558-955627-955701/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# PrisMax V2-US, Hemodialysis Delivery System, Product Codes: 955626, 955558, 955627, 955701 — FDA record Z-2437-2025

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Jul 28, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: PrisMax V2-US, Hemodialysis Delivery System, Product Codes: 955626, 955558, 955627, 955701
- **Reason**: Low deaeration chamber level at post priming tests may lead to PrisMax System alarm T2309: Air Detected in Prime resulting in multiple additional priming cycles
- **Classification**: Class II
- **Recalling firm**: VANTIVE US HEALTHCARE LLC
- **Quantity**: 4772 units
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-2437-2025

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2437-2025%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | UDI 00085412639499, All Serial Numbers |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

Worldwide

No US distribution state could be established from this record. Check the official notice.

## Dates in the source

- **Report date**: Sep 3, 2025
- **Recall initiation date**: Jul 28, 2025
- **Center classification date**: Aug 26, 2025

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2437-2025%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [VANTIVE US HEALTHCARE LLC records](https://isitonrecall.com/brand/vantive-us-healthcare-llc/)