RegWardenFDA facility compliance records
Facility

RENOVO, INC.

1 recall(s) on record — most severe on record: Class II.

Activity by year

FDA actions on record by year2018: 1 inspections; 2021: 1 recalls; 2023: 1 inspections, 1 warning letters2017120182019202012021202222023202420252026
  • Recalls (1)
  • Inspections (2)
  • Warning letters (1)

Devices registered here (3)

  • Electrosurgical, Cutting & Coagulation & Accessories
    Product code GEI (opens in a new tab) · Class II · General, Plastic Surgery · 21 CFR 878.4400
  • Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
    Product code NUJ (opens in a new tab) · Class II · General, Plastic Surgery · 21 CFR 878.4400
  • Arthroscope
    Product code HRX (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.1100

Recalls & enforcement

FDA inspections (2)

  • NAI2023-05-18
    No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
  • NAI2018-06-21
    No Action Indicated · Compliance: Devices; Postmarket Assurance: 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.

FDA warning letters (1)

Source: U.S. FDA Compliance Actions Dashboard (opens in a new tab) (device warning letters, 2016–present). Data as of 2026-10-06. Each link opens an FDA search for the letter; FDA can take several weeks to post a letter, so a very recent one may not appear yet.

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. “RENOVO, INC. (FEI 3014023545) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3014023545-renovo-inc/

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