Nakanishi recalls SGA-E2G surgical handpieces with outdated cleaning instructions.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 SGA-E2G) because old user manuals had incorrect sterilization instructions. Using the old manuals could lead to improper cleaning and potential infection risks.
The old manuals provided incorrect sterilization steps. If dental professionals use the outdated instructions, the handpieces might not be properly cleaned or sterilized, increasing infection risk during surgery.
Dental professionals using Nakanishi SGA-E2G surgical handpieces with serial numbers BL600026 to BL600031 are affected. Those who follow outdated cleaning procedures may face infection risks.
Check for the model SGA-E2G with order code H184 and serial numbers BL600026 to BL600031. The product was sold with the previous operation manual OM-H0035E001.
Remove the previous operation manual OM-H0035E001 and install the new updated manual for correct sterilization procedures.
The recall is due to outdated cleaning instructions in the previous operation manual that could lead to improper sterilization of the surgical handpieces.
The affected models are SGA-E2G with order code H184 and serial numbers BL600026 to BL600031.
No, you do not need to stop using the handpiece. The recall requires updating the operation manual for safe sterilization.
We’ve drafted a message you can send Nakanishi to request your refund or repair — edit it as you like.
Subject: Recall Z-0222-2019 — Nakanishi Nakanishi Hello, I own a Nakanishi that is covered by recall Z-0222-2019 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.
