Micro Surgery Handpiece SGS — Class II medical device recall Z-0223-2019

Terminated recall by Nakanishi Inc., reported 2018-10-31, distributed in CA, FL, GA, IL, WA. Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cl

Recall number	`Z-0223-2019`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Nakanishi Inc., Kanuma, N/A, Japan
Recall initiated	2018-06-01
Classified	2018-10-23
Reported by FDA	2018-10-31
Terminated	2021-04-28
Distributed	CA, FL, GA, IL, WA
Countries outside the US	CA
Quantity	2,419
Serial numbers	`0BB20112`, `0BB20116`, `0BB20226`, `0BB20229`, `0BB40071`, `0BB40075`, `0BB50185`, `0BB50186`, `0BB50189`, `0BB50190`, `0BB50192`, `0BB50215`, `0BB50224`, `0BB50263`, `0BB50265`, `0BB50266`, `0BB60051`, `0BB60055`, `0BB60079`, `0BB60100`, `0BB60106`, `0BB60118`, `0BB70066`, `0BB70100`, `0BB90004` and 128 more

Product

Micro Surgery Handpiece SGS, Model: SGS-ES, Order Code: H264, Manufactured by: Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drilling and tapping the maxilla and mandible.

Reason for recall

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0223-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.