Class II — RenovoRx, Inc.
| Recalling firm | RenovoRx, Inc. |
|---|---|
| Registered facility | RENOVORX, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Incorrect version of Instructions for Use were shipped to two US customers. |
| 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. |
| Quantity | 11 units |
| Distribution | US Distribution to the states of : CA and FL. |
| Initiated | 2015-11-25 |
| Classified | 2015-12-31 |
| Terminated | 2016-02-29 |
| Recall number | Z-0565-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — RenovoRx, Inc. (Z-0565-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/72810/
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