RenovoCath RC 120 — Class II medical device recall Z-0565-2016
Terminated recall by RenovoRx, Inc., reported 2016-01-06, distributed in CA, FL. Incorrect version of Instructions for Use were shipped to two US customers.
| Recall number | Z-0565-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | RenovoRx, Inc., Los Altos, CA, United States |
| Recall initiated | 2015-11-25 |
| Classified | 2015-12-31 |
| Reported by FDA | 2016-01-06 |
| Terminated | 2016-02-29 |
| Distributed | CA, FL |
| Quantity | 11 units |
| Lot numbers | 2016-07, B2456974A, B2457150A |
| Model numbers | MMRC120-DB-1111 |
Product
RenovoCath RC 120; Temporary Intravascular Occluding Catheter Model number: MMRC120-DB-1111; Rx only. Cardiovascular: The RenovoCath RC120 Catheter is intended for the isolation of blood flow and delivery of fluids, including diagnostic and/or therapeutic agents, to selected sites in the peripheral vascular system.
Reason for recall
Incorrect version of Instructions for Use were shipped to two US customers.
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-0565-2016. 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.