Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Surgical Handpiece Recalled by Nakanishi Inc. Due to Reprocessing instructions for the SGS/SGA Surgical Handpieces have...

Date: June 1, 2018
Company: Nakanishi Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Nakanishi Inc. directly.

Affected Products

Surgical Handpiece, Model: SGA-E2G Order Code: H184, Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drilling and tapping the maxilla and mandible.

Quantity: 6

Why Was This Recalled?

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 manuals.

Where Was This Sold?

This product was distributed to 5 states: CA, FL, GA, IL, WA

Affected (5 states)Not affected

About Nakanishi Inc.

Nakanishi Inc. has 11 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report