RegWardenFDA facility compliance records
Facility

ENDOPLUS

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

Activity by year

FDA actions on record by year2013: 1 recalls; 2017: 1 inspections; 2022: 1 inspections; 2026: 1 inspections1’13’14’15’161’17’18’19’20’211’22’23’24’251’26
  • Recalls (1)
  • Inspections (3)

Devices registered here (1)

  • Coagulator, Culdoscopic (And Accessories)
    Product code HFI (opens in a new tab) · Class II · Obstetrics/Gynecology · 21 CFR 884.4160

Recalls & enforcement

FDA inspections (3)

  • NAI2026-02-25
    No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
  • NAI2022-09-08
    No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
  • NAI2017-08-02
    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.

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. “ENDOPLUS (FEI 3000719482) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3000719482-endoplus/

Not open yet

Alerts for ENDOPLUS

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.