RegWardenFDA facility compliance records
Company

NAKANISHI INC.

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

Recalls by year

FDA actions on record by year2016: 1 recalls; 2018: 1 recalls1201620171201820192020202120222023202420252026
  • Recalls (2)

Registered facilities (2)

Recalls & enforcement

  • Class IITerminated2018-06-01
    Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cleaning and specific parameters for autoclave sterilization . The previous operation manuals associated with the SGS/SGA products must be replaced by new operation manual…
  • Class IITerminated2016-07-08
    Through an error, the labeling failed to include the symbol or other text indicating that the diamond coated tips were single use only. A contributing factor to this error is that in other markets such as Japan, the diamond coated tips are multiple use and are not limited to sin…

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “NAKANISHI INC. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-8030216-nakanishi-inc/

Not open yet

Alerts for NAKANISHI INC.

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.