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.
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, but the source text describes an update to reprocessing instructions and manual replacement without reporting any illnesses, injuries, or specific contamination hazards, fitting the criteria for a moderate, precautionary labeling/instruction update.
Plain-English summary
Nakanishi Inc. is recalling 18 units of the SGA-E Surgical Handpiece (Order Code: H083). These devices are intended for surgical use, specifically for drilling and tapping the maxilla and mandible during dental implant procedures.
The recall is being conducted because the reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated. The new instructions include requirements 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 units were distributed in the United States to California, Florida, Georgia, Illinois, and Washington, as well as internationally to Canada. Users of these devices should stop using the previous operation manuals and utilize the updated reprocessing instructions provided by the manufacturer.
The recalled product
- 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.
- Manufacturer
- Nakanishi Inc.
- Hazard
- Affected units
- 18
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 (3)
- Previous Operation Manual: OM-H0035E001 Model Name: SGA-E
- Order Code: H083 FL800010-FL800020
- FLY00001-FLY00007.
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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