Reported Aug 26, 2026 · Ongoing · Updated Sep 16, 2026
Paragonix Technologies Inc. KidneyVault Portable Renal Perfusion System REF# PRGNX-8008-001
Paragonix Technologies Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Paragonix Technologies Inc. · 639 Granite St Ste 408 · Braintree, MA · 02184-5369
Is this the product you have?
- Paragonix Technologies Inc. KidneyVault Portable Renal Perfusion System REF# PRGNX-8008-001
- Lot codes and dates
- All Serial Numbers/UDI00850005470342
- Software VersionParagonix App Ver. 6.1.1/6.1.2
- Amount recalled
- 1445 systems
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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