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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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, but the source text describes a documentation and instruction update regarding reprocessing parameters without reporting any illnesses, injuries, or specific contamination events, fitting the criteria for a moderate, precautionary recall.
Plain-English summary
Nakanishi Inc. is recalling six units of the SGA-E2G Surgical Handpiece (Order Code: H184, Serial Nos. BL600026 - BL600031). The recall is necessary because the reprocessing instructions for these devices have been updated to include instructions for manual cleaning and specific parameters for autoclave sterilization. The previous operation manuals associated with these products must be replaced by new operation manuals.
The affected devices were distributed in the United States to California, Florida, Georgia, Illinois, and Washington, as well as internationally to Canada. These surgical handpieces are intended for surgical use, including drilling and tapping the maxilla and mandible for dental implant use.
Healthcare providers and facilities that have received these specific serial numbers should stop using the previous operation manual (OM-H0035E001) and utilize the updated reprocessing instructions to ensure proper cleaning and sterilization.
The recalled product
- 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.
- Manufacturer
- Nakanishi Inc.
- Affected units
- 6
Distribution
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
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