Paragonix KidneyVault Portable Renal Perfusion System Recall
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Paragonix Technologies Inc. is recalling 1,445 KidneyVault Portable Renal Perfusion Systems due to a firmware defect that may cause a blank screen and loss of displayed preservation parameters.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on September 8, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, MedicalDevices.
What Happened
Paragonix Technologies Inc. initiated a voluntary recall of its KidneyVault Portable Renal Perfusion System 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.
Which Products Are Affected
The recall affects Paragonix Technologies Inc. KidneyVault Portable Renal Perfusion System, REF# PRGNX-8008-001. A total of 1,445 systems are involved. All serial numbers are affected with UDI 00850005470342 and software versions Paragonix App Ver. 6.1.1/6.1.2. The products were distributed nationwide in the United States, including 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, and OR.
What You Should Do
Consumers and healthcare facilities should contact Paragonix Technologies Inc. regarding the recall. Further details are available through the recalling firm.
Why This Matters
This Class II recall involves a device used for organ preservation where the firmware issue could result in loss of critical displayed parameters.
Source
FDA recall number Z-2967-2026. https://www.fda.gov
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,276 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to September 8, 2026.
Frequently Asked Questions
Common questions about this FDA recall.