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.
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: This is an FDA Class II recall involving updated reprocessing instructions and manual replacement. There are no reported illnesses or injuries, and the hazard is procedural rather than a direct physical defect, fitting the criteria for a moderate severity score.
Plain-English summary
Nakanishi Inc. is recalling 1,662 units of the Micro Surgery Handpiece SGS, Model SGS-E2S (Order Code H266). These surgical handpieces are intended for dental implant use, including drilling and tapping the maxilla and mandible.
The recall is being conducted because the reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated. The new instructions include specific parameters for manual cleaning and 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. Consumers and healthcare providers should stop using the affected handpieces and replace the previous operation manuals with the updated versions provided by the manufacturer.
The recalled product
- 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..
- Manufacturer
- Nakanishi Inc.
- Affected units
- 1,662
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: SGS-E2S
- Order Code H266 Serial Nos.:0LZ00004 -0LZ00013
- 0LZ00015- 0LZ00018
- 0LZ00021 - 0LZ00030
- 0LZ00036 - 0LZ00040
- 0LZ00043- 0LZ00054
- 0BB30001-0BB30010
- 0BB30012 - 0BB30015
- 0LZ00058
- 0BB30022 - 0BB30026
- 0BB50001-0BB50013
- 0BB50021 - 0BB50025
- 0BB70003 - 0BB70015
- 0BB90007-0BB90027
- 0BBX0001 - 0BBX0010
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
Same manufacturer · Nakanishi Inc.
See all →- ModerateNakanishi Surgical Handpieces Recalled for Updated Reprocessing Instructions
FDA (Devices) · 2018-10-31
- ModerateNakanishi Micro Surgery Handpiece Recall for Updated Reprocessing Instructions
FDA (Devices) · 2018-10-31
- ModerateNakanishi Surgical Handpiece Recall for Updated Reprocessing Instructions
FDA (Devices) · 2018-10-31
- ModerateNakanishi Surgical Handpiece Recall for Updated Reprocessing Instructions
FDA (Devices) · 2018-10-31
- ModerateNakanishi SGA-E Surgical Handpieces Recalled for Updated Reprocessing Instructions
FDA (Devices) · 2018-10-31
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