RegWardenFDA facility compliance records
Facility

UROLOGIX, LLC

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

Activity by year

FDA actions on record by year2013: 1 recalls; 2016: 1 inspections; 2022: 1 inspections; 2026: 1 inspections1’13’14’151’16’17’18’19’20’211’22’23’24’251’26
  • Recalls (1)
  • Inspections (3)

Devices registered here (2)

  • Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
    Product code KNS (opens in a new tab) · Class II · Gastroenterology, Urology · 21 CFR 876.4300
  • Electrosurgical, Cutting & Coagulation & Accessories
    Product code GEI (opens in a new tab) · Class II · General, Plastic Surgery · 21 CFR 878.4400

Recalls & enforcement

FDA inspections (3)

  • VAI2026-07-01
    Voluntary Action Indicated · Compliance: Devices · citations posted
  • NAI2022-03-18
    No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
  • NAI2016-11-16
    No 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. “UROLOGIX, LLC (FEI 3000718675) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3000718675-urologix-llc/

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