Nakanishi recalls SGS-E surgical handpieces with outdated cleaning instructions. Owners must replace old manuals with new ones to ensure safe sterilization.
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 surgical handpieces (model SGS-E) because old operation manuals had incorrect cleaning and sterilization instructions. This could lead to improper sterilization if users follow outdated steps.
The old manuals had incorrect cleaning and sterilization steps. If users follow these outdated instructions, the handpieces might not sterilize properly, increasing infection risk during surgery.
Dental professionals using Nakanishi SGS-E surgical handpieces with serial numbers FL400001-FL400015 are affected. Those who still have the old operation manual are at higher risk.
Check for serial numbers FL400001-FL400015, FL500008-FL500010, or FL400012-FL400015 on the handpiece. The old operation manual (OM-H0035E001) should be replaced with the new one.
Remove the previous operation manual (OM-H0035E001) and install the new one with updated cleaning and sterilization instructions.
The old operation manuals had incorrect cleaning and sterilization instructions that could lead to improper sterilization of the surgical handpieces.
The affected models are SGS-E with order code H084 and serial numbers FL400001-FL400015, FL500008-FL500010, and FL400012-FL400015.
No, you do not need to stop using the handpiece. The recall involves updating the operation manual for proper cleaning and sterilization.
We’ve drafted a message you can send Nakanishi to request your refund or repair — edit it as you like.
Subject: Recall Z-0219-2019 — Nakanishi Nakanishi Hello, I own a Nakanishi that is covered by recall Z-0219-2019 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.
