Nakanishi recalls SGA-E surgical handpieces with outdated cleaning instructions.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Nakanishi is recalling SGA-E surgical handpieces due to outdated cleaning instructions in previous manuals. This could lead to improper sterilization if users follow old procedures.
Old manuals may provide incorrect cleaning steps for sterilization. If users follow outdated instructions, the handpieces might not sterilize properly, risking infection during surgery.
Dental professionals using SGA-E handpieces with order code H083 are affected. Those who have the old operation manual (OM-H0035E001) are most at risk.
Check for model SGA-E and order code H083 on the handpiece. Look for the old operation manual OM-H0035E001.
Remove the previous operation manual (OM-H0035E001) and replace it with the new instructions.
The previous operation manual had outdated cleaning instructions for sterilization. New manuals with correct steps are required.
No, but you must replace the old manual with the new instructions to ensure proper sterilization.
The official notice doesn't specify this. Check with Nakanishi for guidance.
We’ve drafted a message you can send Nakanishi to request your refund or repair — edit it as you like.
Subject: Recall Z-0221-2019 — Nakanishi Nakanishi Hello, I own a Nakanishi that is covered by recall Z-0221-2019 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.
