Nakanishi recalls SGA-ES surgical handpieces with outdated operation manuals.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Nakanishi is recalling certain Micro Surgery Handpiece SGA-ES models due to outdated operation manuals. These manuals no longer include correct cleaning and sterilization instructions, which could lead to improper use if followed.
The previous operation manuals provided incorrect cleaning and sterilization instructions for the handpieces. Using the outdated manuals could result in improper sterilization, potentially leading to infection risks during dental procedures.
Dental professionals using the SGA-ES handpieces with outdated operation manuals (OM-SH0015E002 to OM-SH0015E005, OM-SH0100F, OM-SH0096S) are most at risk. The recall affects specific model ranges sold between 2010 and 2015.
Check for model SGA-ES with order code H263. The affected units have specific serial numbers listed in the recall notice, including ranges like 0BB10068-0BB10069 and 0BB20006-0BB20010.
Remove and replace outdated operation manuals (OM-SH0015E002 to OM-SH0015E005, OM-SH0100F, OM-SH0096S) with the new cleaning and sterilization instructions.
The previous operation manuals had outdated cleaning and sterilization instructions for the SGA-ES handpieces. The new instructions ensure proper sterilization to prevent infection risks.
The affected models are SGA-ES with order code H263, including specific serial number ranges like 0BB10068-0BB10069 and 0BB20006-0BB20010.
No, the recall does not require stopping use. Users must replace outdated manuals with the new instructions to ensure proper sterilization.
We’ve drafted a message you can send Nakanishi to request your refund or repair — edit it as you like.
Subject: Recall Z-0225-2019 — Nakanishi Nakanishi Hello, I own a Nakanishi that is covered by recall Z-0225-2019 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.
