The Recall Desk

Manufacturer

Nakanishi Inc.

11 recalls in our database name Nakanishi Inc. as the manufacturing or recalling firm.

What the numbers show

Total
11
Critical
0
Severe
0
Most recent
2018-10-31

Of the 11 recalls from Nakanishi Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–11 of 11

  • ModerateFDA (Devices)·Z-0222-2019·2018-10-31

    Nakanishi Surgical Handpieces Recalled for Updated Reprocessing Instructions

    Nakanishi Inc. is recalling six SGA-E2G surgical handpieces because reprocessing instructions have been updated to include manual cleaning and specific autoclave parameters.

    Product
    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.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0224-2019·2018-10-31

    Nakanishi SGS Surgical Handpieces Recalled for Updated Reprocessing Instructions

    Nakanishi Inc. is recalling 1,662 SGS-E2S surgical handpieces because reprocessing instructions were updated to include manual cleaning and specific autoclave parameters.

    Product
    Micro Surgery Handpiece SGS, Model: SGS-E2S, Order Code: H266, Manufactured by: 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..
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0219-2019·2018-10-31

    Nakanishi Surgical Handpiece Recall for Updated Reprocessing Instructions

    Nakanishi Inc. is recalling 12 SGS-E surgical handpieces to replace operation manuals with updated reprocessing instructions for manual cleaning and autoclave sterilization.

    Product
    Surgical Handpiece, Model: SGS-E, Order Code: H084, 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.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0220-2019·2018-10-31

    Nakanishi Surgical Handpiece Recall for Updated Reprocessing Instructions

    Nakanishi Inc. is recalling SGS-E2G surgical handpieces to replace operation manuals with updated reprocessing instructions for manual cleaning and autoclave sterilization.

    Product
    Surgical Handpiece, Model: SGS-E2G Order Code: H185, 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.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0221-2019·2018-10-31

    Nakanishi SGA-E Surgical Handpieces Recalled for Updated Reprocessing Instructions

    Nakanishi Inc. is recalling 18 SGA-E surgical handpieces because reprocessing instructions were updated to include manual cleaning and specific autoclave sterilization parameters.

    Product
    Surgical Handpiece, Model: SGA-E Order Code: H083, 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.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0226-2019·2018-10-31

    Nakanishi Micro Surgery Handpiece Recall for Updated Reprocessing Instructions

    Nakanishi Inc. is recalling 1,878 Micro Surgery Handpiece SGA units to replace operation manuals with updated reprocessing and sterilization instructions.

    Product
    Micro Surgery Handpiece SGA, Model SGA-E2S Order Code: H265, Manufactured by: 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.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0223-2019·2018-10-31

    Nakanishi SGS-ES Micro Surgery Handpiece Recall for Updated Instructions

    Nakanishi Inc. is recalling 2,419 SGS-ES Micro Surgery Handpieces to replace operation manuals with updated reprocessing and sterilization instructions.

    Product
    Micro Surgery Handpiece SGS, Model: SGS-ES, Order Code: H264, Manufactured by: 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.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0225-2019·2018-10-31

    Nakanishi Micro Surgery Handpiece Recall for Updated Reprocessing Instructions

    Nakanishi Inc. is recalling 440 Micro Surgery Handpiece SGA units because reprocessing instructions have been updated. Previous operation manuals must be replaced.

    Product
    Micro Surgery Handpiece SGA, Model SGA-ES, Order Code:H263, Manufactured by: 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.
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-2674-2016·2016-09-07

    Nakanishi Diamond Coated Dental Tips Recalled for Missing Single-Use Labeling

    Nakanishi Inc. is recalling 4,284 diamond coated dental tips because the packaging failed to indicate they are single-use only, posing a risk of cross-contamination.

    Product
    Diamond Coated Tips and Burs are accessories to the air powered dental handpiece (S-MAX pico) The intended use of the tips is based on the parent device. For burs used with the dental handpieces, the intended use is general dental actions such as removing carious material, reduc
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2673-2016·2016-09-07

    Nakanishi Diamond Coated Tips Recalled for Missing Single-Use Labeling

    Nakanishi Inc. is recalling 2,574 diamond coated tips and burs because the labeling failed to indicate they are single-use only, posing a cross-contamination risk.

    Product
    Diamond Coated Tips and Burs are accessories to the air powered Bone drill (VARIOSURG with and without light) The intended use of the tips is based on the parent device. For the VarioSurg, in addition to the scaling functions, diamond coated tips are used for socket lift, sinus
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2672-2016·2016-09-07

    Nakanishi Diamond Coated Tips Recalled for Missing Single-Use Labeling

    Nakanishi Inc. is recalling 30,719 diamond coated tips and burs because labeling failed to indicate they are single-use only, posing a cross-contamination risk.

    Product
    Diamond Coated Tips and Burs are accessories to the Ultrasonic Scaler (VARIOS 350 LUX, VARIOS 350, VARIOS 150 LUX, VARIOS 150). The intended use of the tips is based on the parent device. For the ultrasonic scalers and the sonic air scaler, the tips are used for various actions
    Category
    Medical Device
    Distribution
    Distributed nationwide