CLASS II ONGOING Device recall · Reported 26 Aug 2026 · FDA Enforcement Report
KidneyVault Portable Renal Perfusion System recalled
Paragonix Technologies is recalling Paragonix Technologies Inc. KidneyVault Portable Renal Perfusion System, distributed nationwide in the US. The recall was initiated on 20 Jul 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2967-2026
- FDA event ID
- 99476
- Recalling firm
- Paragonix Technologies, Braintree, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 20 Jul 2026
- FDA classified
- 14 Aug 2026
- Reported
- 26 Aug 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 20 Jul 2026 | Recall initiated by company | |
| 14 Aug 2026 | Classified by FDA | +25 days |
| 26 Aug 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Paragonix Technologies Inc. KidneyVault Portable Renal Perfusion System REF# PRGNX-8008-001
Where it was distributed
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.
Nationwide AlabamaArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaFloridaGeorgiaHawaiiIllinoisIndianaKentuckyLouisianaMassachusettsMarylandMichiganMinnesotaMissouriMississippiNorth Carolina
Questions about this recall
Is KidneyVault Portable Renal Perfusion System recalled?
Yes. Paragonix Technologies recalled KidneyVault Portable Renal Perfusion System on 20 Jul 2026. The recall is Class II and its status is Ongoing. Recall number Z-2967-2026.
Why was it 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.
Which lots are affected?
All Serial Numbers/UDI: 00850005470342 Software Version: Paragonix App Ver. 6.1.1/6.1.2
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |