Micro Surgery Handpiece SGA — Class II medical device recall Z-0226-2019
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-0226-2019 |
|---|---|
| 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 | 1,878 |
| Model numbers | GA-E2S |
Product
Micro Surgery Handpiece SGA, Model SGA-E2S Order Code: H265, 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-0226-2019. 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.