The Recall Desk
HighFDA (Devices)·Z-2967-2026·Announced 2026-08-26

Paragonix KidneyVault Portable Renal Perfusion System Recalled for Firmware Defect

Paragonix Technologies is recalling 1,445 KidneyVault Portable Renal Perfusion Systems because a firmware defect may cause the device to lose configuration, resulting in a blank screen and loss of displayed preservation parameters.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a risk-of-harm product (medical device) where the loss of displayed preservation parameters could impact patient safety, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Paragonix Technologies Inc. is recalling 1,445 KidneyVault Portable Renal Perfusion Systems (REF# PRGNX-8008-001) due to a firmware defect. The affected devices are identified by Serial Numbers/UDI 00850005470342 and Software Version Paragonix App Ver. 6.1.1/6.1.2.

The defect may cause the portable organ transfer device datalogger to lose its configuration. This can result in a blank screen and the loss of displayed preservation parameters. The recall covers units distributed nationwide in the United States, including specific states and territories such as AL, AZ, CA, TN, FL, HI, MN, NJ, TX, UT, CO, CT, DC, MD, GA, KY, LA, MA, MI, MO, MS, NC, ND, NE, NM, NV, NY, PA, PR, SC, VA, WI, WV, IN, OH, IL, and OR.

Healthcare facilities and users should contact Paragonix Technologies Inc. for instructions on how to address the firmware defect and ensure the device is functioning correctly.

The recalled product

Product
Paragonix Technologies Inc. KidneyVault Portable Renal Perfusion System REF# PRGNX-8008-001
Manufacturer
Paragonix Technologies Inc.
Category
Medical Device — Portable Renal Perfusion System
Hazard
Affected units
1,445

Distribution

Distributed nationwide across the United States.

The notice also names 37 states specifically:

Related recalls

Same hazard · firmware defect

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