Nakanishi SGS-ES Micro Surgery Handpiece Recall for Updated Instructions
Nakanishi Inc. is recalling 2,419 SGS-ES Micro Surgery Handpieces to replace operation manuals with updated reprocessing and sterilization instructions.
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 corresponds to a moderate severity level. The hazard involves updated instructions for sterilization, which is a procedural correction rather than a reported injury or critical defect.
Plain-English summary
Nakanishi Inc. is recalling 2,419 units of the Micro Surgery Handpiece SGS, Model SGS-ES (Order Code H264). The recall is initiated to replace previous operation manuals with new ones that include updated instructions for manual cleaning and specific parameters for autoclave sterilization.
The affected handpieces are intended for surgical use, including dental implant drilling and tapping. The 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 new versions provided by the manufacturer to ensure proper reprocessing and sterilization.
The recalled product
- Product
- Micro Surgery Handpiece SGS, Model: SGS-ES, Order Code: H264, 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.
- Hazard
- Affected units
- 2,419
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-ES
- Order Code H264/H264007 Serial Nos.:0LZ00063 - 0LZ00064
- 0LZ00066 - 0LZ00068
- 0LZ00070 - 0LZ00109
- 0LZ00110 - 0LZ00115
- 0BB20112 -0BB20116
- 0BB20226 - 0BB20229
- 0BB40071 - 0BB40075
- 0BB50186 - 0BB50189
- 0BB50215 - 0BB50224
- 0BB50263
- 0BB50265
- 0BB50266
- 0BB50185
- 0BB50190 - 0BB50192
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 SGS Surgical Handpieces Recalled 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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