Paragonix recalls its KidneyVault Portable Renal Perfusion System (REF# PRGNX-8008-001) due to a firmware defect that may cause a blank screen and loss of preservation parameters. Affected units have specific serial numbers and software versions.
Due to a firmware defect, the portable organ transfer device datalogger may lose its configuration, resulting in a blank screen and loss of displayed preservation parameters.
“Paragonix KidneyVault Portable Renal Perfusion System Recall: Firmware Defect Causes Blank.” GovInfoNow, updated September 14, 2026. https://govinfonow.com/recall/697855-paragonix-kidneyvault-portable-renal-perfusion-system-recall-firmware-defect-causes. Based on FDA recall #Z-2967-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2967-2026%22&limit=1).
The FDA announced on July 20, 2026, that Paragonix Technologies Inc. is recalling its KidneyVault Portable Renal Perfusion System due to a firmware defect that may cause the device's screen to go blank and lose preservation parameters. This voluntary Class II recall affects 1,445 systems distributed nationwide.
How to tell if you have it
Brand: Paragonix
Product: KidneyVault Portable Renal Perfusion System
REF#: PRGNX-8008-001
Serial Numbers/UDI: 00850005470342
Software Version: Paragonix App Ver. 6.1.1/6.1.2
The hazard
According to the FDA, a firmware defect in the portable organ transfer device datalogger may cause it to lose its configuration. This results in a blank screen and loss of displayed preservation parameters.
Context
GovInfoNow's records show other recent recalls of similar medical products include the Fresenius 5008X Blood Tubing Set Recall dated May 11, 2026, and the Baxter Novum IQ Syringe Pump Recall dated August 11, 2026.
How to tell if you have this one
Check for the product name 'KidneyVault Portable Renal Perfusion System' with serial numbers starting with 00850005470342 and software versions 6.1.1 or 6.1.2.
Brand
Paragonix
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Status
Verify if the device shows a blank screen or loses preservation parameters.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 35 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states and territories of 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, UT, VA, WI, WV, IN, OH, KY, IL, MD, MN, OR.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Illinois, Indiana, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, West Virginia, Wisconsin.
Recall timeline
FDA published this recall 37 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4Added to GovInfoNow
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2967-2026 (July 20, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2967-2026 to see it in context.
Plain-language summary written by qwen3:4b on September 14, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.