Nakanishi recalls SGS-E2G surgical handpieces due to outdated cleaning instructions in previous manuals. Updated manuals require specific autoclave sterilization parameters to prevent infection risks during dental procedures.
Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cleaning and specific parameters for autoclave sterilization . The previous operation manuals associated with the SGS/SGA products must be replaced by new operation manuals.
Nakanishi is recalling SGS-E2G surgical handpieces because older manuals had incorrect cleaning instructions. This could lead to improper sterilization and infection risks during dental procedures if users follow outdated steps.
The previous manuals provided incorrect cleaning instructions that could lead to improper sterilization. If dental professionals use the handpieces without following the updated cleaning protocols, there's a risk of infection during procedures.
Dental professionals who own or use SGS-E2G handpieces with outdated manuals are affected. The risk is low as the hazard involves procedural errors rather than immediate physical harm.
Check for the model SGS-E2G with order code H185. These handpieces were sold in the U.S. market starting from 2011, but no shipments occurred between 2011 and April 2018.
Replace the old manual with the new operation manual that includes updated cleaning and autoclave sterilization parameters.
No shipments of SGS-E2G handpieces occurred between 2011 and April 2018 to the U.S. market.
No, but you must update the cleaning instructions using the new manual to prevent infection risks.
Replace the old manual with the new operation manual that includes updated cleaning and autoclave sterilization parameters.
We’ve drafted a message you can send Nakanishi to request your refund or repair — edit it as you like.
Subject: Recall Z-0220-2019 — Nakanishi Nakanishi Hello, I own a Nakanishi that is covered by recall Z-0220-2019 from Nakanishi. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.