RENOVORX, INC.
1 recall(s) on record — most severe on record: Class II.
Activity by year
- Recalls (1)
- Inspections (3)
Devices registered here (1)
- Catheter, Intravascular Occluding, TemporaryProduct code MJN (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.4450
Recalls & enforcement
- Class IITerminated2015-11-25Incorrect version of Instructions for Use were shipped to two US customers.
FDA inspections (3)
- NAI2026-06-16No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
- VAI2022-04-04Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
- NAI2016-05-18No Action Indicated · Compliance: Devices
Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.
Related
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)
Cite this record
RegWarden. “RENOVORX, INC. (FEI 3011279674) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3011279674-renovorx-inc/
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