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.
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, which corresponds to a moderate severity score. The issue involves updated reprocessing instructions rather than a reported injury or a high-risk pathogen, fitting the criteria for minor labeling or documentation issues.
Plain-English summary
Nakanishi Inc. is recalling 12 units of the SGS-E Surgical Handpiece (Order Code: H084) to replace previous operation manuals. The recall is necessary because reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated to include specific parameters for manual cleaning and autoclave sterilization.
The affected units are identified by serial numbers FL400001 through FL400005, FL500008 through FL500010, and FL400012 through FL400015. These devices were distributed in the United States to California, Florida, Georgia, Illinois, and Washington, as well as internationally to Canada. The handpieces are intended for surgical use, including drilling and tapping the maxilla and mandible for dental implants.
Users should replace the previous operation manual (OM-H0035E001) with the new operation manual to ensure proper reprocessing of the devices.
The recalled product
- 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.
- Manufacturer
- Nakanishi Inc.
- Hazard
- Affected units
- 12
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 (4)
- Previous Operation Manual: OM-H0035E001 Model Name: SGS-E Order Code: H084
- Serial Nos. FL400001 - FL400005
- FL500008 - FL500010
- FL400012-FL400015.
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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See all →- ModerateNakanishi Surgical Handpieces Recalled for Updated Reprocessing Instructions
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