Paragonix Technologies Inc — Class II medical device recall Z-2967-2026
Ongoing recall by Paragonix Technologies Inc., reported 2026-08-26, distributed nationwide. Due to a firmware defect, the portable organ transfer device datalogger may lose its configuration, resulting
| Recall number | Z-2967-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Paragonix Technologies Inc., Braintree, MA, United States |
| Recall initiated | 2026-07-20 |
| Classified | 2026-08-14 |
| Reported by FDA | 2026-08-26 |
| Distributed | Nationwide (US) |
| Quantity | 1,445 systems |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00850005470342 |
| Model numbers | PRGNX-8008-001 |
Product
Paragonix Technologies Inc. KidneyVault Portable Renal Perfusion System REF# PRGNX-8008-001
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2967-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.