CLASS II Device recall · Reported 31 Oct 2018 · FDA Enforcement Report
Micro Surgery Handpiece SGA recalled by Nakanishi
Nakanishi is recalling Micro Surgery Handpiece SGA, distributed nationwide in the US. The recall was initiated on 1 Jun 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0225-2019
- FDA event ID
- 80713
- Recalling firm
- Nakanishi, Kanuma, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Jun 2018
- FDA classified
- 23 Oct 2018
- Reported
- 31 Oct 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Surgical Instruments
Timeline
| 1 Jun 2018 | Recall initiated by company | |
| 23 Oct 2018 | Classified by FDA | +144 days |
| 31 Oct 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Micro Surgery Handpiece SGA, Model SGA-ES, Order Code:H263, 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.
Where it was distributed
U.S. Distribution to states of: CA, FL, GA, IL, WA.; and internationally to: Canada.
Questions about this recall
Is Micro Surgery Handpiece SGA recalled?
Yes. Nakanishi recalled Micro Surgery Handpiece SGA on 1 Jun 2018. The recall is Class II and its status is Terminated. Recall number Z-0225-2019.
Why was it recalled?
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.
Which lots are affected?
Previous Operation Manuals: OM-SH0015E002, OM-SH0015E003, OM-SH0015E004, OM-SH0015E005, OM-SH0100F, OM-SH0096S. Model Name: SGA-ES Order Code: H263 0BB10068 - 0BB10069; 0BB20006 -0BB20010; 0BB30044-0BB30046, 0BB30051 - 0BB30053; 0BB60035 - 0BB60042; 0BB70021, 0BB70022, 0BB70025, 0BB70026, 0BB60063 - 0BB60072; 0BB70020, 0BB70023, 0BB70024,0BBX0042 - 0BBX0044; 0BC10046 - 0BC10070; 0BC20053 - 0BC20060; 0BC30011 - 0BC30014, 0BC30081 -0BC30087; 0BC40041- 0BC40043; 0BC40054 -0BC40063; 0BC50009- 0BC50018; 0BC50041-0BC50044, 0BC50046- 0BC50055, 0BC50065, 0BC50066, 0BC50073, 0BC50074, 0BC60010- 0BC60019; 0BC90031 - 0BC90035; 0BCY0086 - 0BCY0095; 0BD50003 -0BD50012; ABDZ0011 -ABDZ0020; ABDZ0083-ABDZ0102, ABDZ0112-ABDZ0117; ABE30001-ABE30015 , ABE30017- ABE30034; ABE40069 - ABE40088, ABE40095, ABE40096, ABE50001- ABE50010, ABE50012- ABE50021; ABE40090; ABE50036 - ABE50040; ABE90009 - ABE90018; ABE90041 - ABE90050; ABEY0001- ABEY0010; ABF40022 - ABF40041; ABF50031- ABF50040; ABF70020 - ABF70025; ABF70058 - ABF70065; ABFY0021- ABFY0030, ABFX0030, ABFY0001 - ABFY0006, ABFY0008-ABFY0010; ABFZ0034- ABFZ0039, ABFZ0041, ABFZ0042, ABFZ0044- ABFZ0053;ABG40011-ABG40022; ABG40024; ABG70128, ABG70129, ABG70131 - ABG70140; ABG80001-ABG80018; ABG90125 -ABG90127, ABG90129, ABG90130, ABG90132, ABG90133; ABH30023.
Where was it sold?
U.S. Distribution to states of: CA, FL, GA, IL, WA.; and internationally to: Canada.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Nakanishi
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Micro Surgery Handpiece SGA recalled by Nakanishi | Nakanishi | Sterility | Nationwide |
| Device | CLASS II | Surgical Handpiece recalled by Nakanishi | Nakanishi | Sterility | Nationwide |
| Device | CLASS II | Surgical Handpiece recalled by Nakanishi | Nakanishi | Sterility | Nationwide |
| Device | CLASS II | Micro Surgery Handpiece SGS recalled by Nakanishi | Nakanishi | Sterility | Nationwide |
| Device | CLASS II | Micro Surgery Handpiece SGS recalled by Nakanishi | Nakanishi | Sterility | Nationwide |
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| Device | CLASS II | Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled | ConMed | Sterility | Nationwide |