Nakanishi Surgical Handpiece Recall for Updated Reprocessing Instructions
Nakanishi Inc. is recalling SGS-E2G 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 a voluntary precautionary measure to update documentation and reprocessing instructions, which aligns with the rubric for minor labeling or documentation issues.
Plain-English summary
Nakanishi Inc. is recalling the SGS-E2G Surgical Handpiece (Order Code: H185) to replace previous operation manuals with updated reprocessing instructions. The new instructions provide specific parameters for manual cleaning and autoclave sterilization.
The recalled handpieces are intended for surgical use, including dental implant drilling and tapping. The distribution included the U.S. states of California, Florida, Georgia, Illinois, and Washington, as well as Canada. There were no shipments of the SGS-E2G model to the U.S. market between 2011 and April 2018.
Users of these devices should replace their existing operation manuals with the new ones containing the updated reprocessing instructions.
The recalled product
- Product
- Surgical Handpiece, Model: SGS-E2G Order Code: H185, 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
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 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 SGA-E Surgical Handpieces Recalled for Updated Reprocessing Instructions
FDA (Devices) · 2018-10-31
Same hazard · documentation error
See all →- ModerateSteris HexaVue Focus Integration System Recalled for Patient Data Mismatch
FDA (Devices) · 2026-10-14
- LowMindray cPM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
- LowMindray Recalls Passport Series Patient Monitor Operator's Manuals
FDA (Devices) · 2026-10-14
- ModerateConMed Suture Anchor Recalled for Incorrect Patient Implant Card
FDA (Devices) · 2026-09-02
- ModerateHenry Schein Recalls Structur 2 SC Temporary Resin Cartridges for Incorrect Packaging
FDA (Devices) · 2026-09-02
Similar recalls
- ModerateStryker Endoscopy Recalls Laparoscopic Manual Instruments Due to Sterilization Documentation Error
FDA (Devices) · 2014-12-24
- ModerateStryker Endoscopy Recalls Laparoscopic Manual Instruments Due to Sterilization Instructions
FDA (Devices) · 2014-12-24
- ModerateStryker Laparoscopic Grasper Recalled Due to Sterilization Instructions
FDA (Devices) · 2014-12-24
- ModerateStryker Laparoscopic Needle Holder Recall Due to Sterilization Instructions
FDA (Devices) · 2014-12-24
- ModerateStryker Endoscopy Recalls Laparoscopic Manual Instruments Due to Sterilization Labeling
FDA (Devices) · 2014-12-24
- ModerateStryker Laparoscopic Instruments Recalled for Sterilization Parameter Errors
FDA (Devices) · 2014-12-24