Nakanishi recalls Micro Surgery Handpiece SGA-E2S models with outdated operation manuals. Users must replace old manuals with new cleaning and sterilization instructions to prevent improper use.
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 Micro Surgery Handpiece SGA-E2S models (Order Code H265) because older operation manuals provided incorrect cleaning and sterilization instructions. Using these outdated manuals could lead to improper surgical tool cleaning and potential safety issues.
The previous operation manuals had outdated instructions for manual cleaning and autoclave sterilization. Following these old instructions could result in improper cleaning, which might lead to contamination or damage to the surgical tools.
Dental professionals who own or use the SGA-E2S Micro Surgery Handpieces with the affected order codes. Those most at risk are users who have not updated to the new operation manuals.
Check for the model name SGA-E2S and order code H265 on the handpiece. The affected units were sold with older operation manuals: OM-SH0015E002, OM-SH0015E003, OM-SH0015E004, OM-SH0015E005, OM-SH0096S, OM-SH0100F.
Remove and discard the previous operation manuals (OM-SH0015E002, OM-SH0015E003, OM-SH0015E004, OM-SH0015E005, OM-SH0096S, OM-SH0100F) and obtain the new operation manuals.
The previous operation manuals had outdated instructions for manual cleaning and autoclave sterilization. The new manuals provide updated cleaning and sterilization parameters to ensure proper use.
The SGA-E2S Micro Surgery Handpieces with Order Code H265, including specific serial number ranges listed in the recall notice.
No, the handpiece itself is safe to use. The recall only requires replacing the outdated operation manuals with the new ones to ensure proper cleaning and sterilization.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-0226-2019 — Nakanishi Nakanishi Hello, I own a Nakanishi that is covered by recall Z-0226-2019 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.
