The Recall Desk
ModerateFDA (Devices)·Z-0225-2019·Announced 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.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product could cause temporary or medically reversible health consequences. The hazard is related to updated reprocessing instructions rather than a structural defect or reported injury, fitting the Moderate severity criteria for procedural updates.

Plain-English summary

Nakanishi Inc. is recalling 440 units of the Micro Surgery Handpiece SGA, Model SGA-ES, Order Code H263. These surgical handpieces are intended for dental implant use, including drilling and tapping the maxilla and mandible. The recall is necessary because reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated to include manual cleaning and specific parameters for autoclave sterilization.

The affected products were distributed in the United States to California, Florida, Georgia, Illinois, and Washington, as well as internationally to Canada. The recall involves specific serial number ranges and previous operation manuals (OM-SH0015E002 through OM-SH0100F) which must be replaced by new operation manuals.

Consumers and healthcare providers should stop using the affected handpieces and replace the previous operation manuals with the updated versions provided by the manufacturer to ensure proper cleaning and sterilization.

The recalled product

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.
Manufacturer
Nakanishi Inc.
Category
Medical Device — Surgical Handpiece
Hazard
Affected units
440

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Previous Operation Manuals: OM-SH0015E002
  • OM-SH0015E003
  • OM-SH0015E004
  • OM-SH0015E005
  • OM-SH0100F
  • OM-SH0096S. Model Name: SGA-ES Order Code: H263 0BB10068 - 0BB10069
  • 0BB20006 -0BB20010
  • 0BB30044-0BB30046
  • 0BB30051 - 0BB30053
  • 0BB60035 - 0BB60042
  • 0BB70021
  • 0BB70022
  • 0BB70025
  • 0BB70026
  • 0BB60063 - 0BB60072
  • 0BB70020
  • 0BB70023
  • 0BB70024
  • 0BBX0042 - 0BBX0044
  • 0BC10046 - 0BC10070

Distribution

Distributed in 5 states:

Part of a larger recall action

This product is one of 8 recalled by Nakanishi Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 8 products in this recall →

Related recalls

Same manufacturer · Nakanishi Inc.

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Same hazard · improper sterilization

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