Recall
Class II — Paragonix Technologies Inc.
| Recalling firm | Paragonix Technologies |
|---|---|
| Registered facility | PARAGONIX TECHNOLOGIES, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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. |
| Product | Paragonix Technologies Inc. KidneyVault Portable Renal Perfusion System REF# PRGNX-8008-001 |
| Quantity | 1445 systems |
| 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. |
| Initiated | 2026-07-20 |
| Classified | 2026-08-14 |
| Recall number | Z-2967-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-09-07. Verify this recall record at FDA → (opens in a new tab)
Watch Paragonix Technologies
We'll email you when a new FDA recall, enforcement, inspection classification, or warning letter is published for a facility you follow.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.