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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80713

8 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
June 01, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Nakanishi Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

8 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 8

Surgical Handpiece, Model: SGS-E, Order Code: H084, 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.

Z-0219-2019
Recall number
Z-0219-2019
Initiated
June 01, 2018
Classification
Class II
Status
Terminated
Recalling firm
Nakanishi Inc.
Quantity
12

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Previous Operation Manual: OM-H0035E001 Model Name: SGS-E Order Code: H084, Serial Nos. FL400001 - FL400005; FL500008 - FL500010; FL400012-FL400015.

Distribution pattern

U.S. Distribution to states of: CA, FL, GA, IL, WA.; and internationally to: Canada.

device · product 2 of 8

Surgical Handpiece, Model: SGS-E2G Order Code: H185, 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.

Z-0220-2019
Recall number
Z-0220-2019
Initiated
June 01, 2018
Classification
Class II
Status
Terminated
Recalling firm
Nakanishi Inc.
Quantity
0

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Model Name: SGS-E2G Order Code: H185 *Note: There were no shipments of SGS-E2G between 2011 and April 2018 to the U.S. Market.

Distribution pattern

U.S. Distribution to states of: CA, FL, GA, IL, WA.; and internationally to: Canada.

device · product 3 of 8

Surgical Handpiece, Model: SGA-E Order Code: H083, 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.

Z-0221-2019
Recall number
Z-0221-2019
Initiated
June 01, 2018
Classification
Class II
Status
Terminated
Recalling firm
Nakanishi Inc.
Quantity
18

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Previous Operation Manual: OM-H0035E001 Model Name: SGA-E, Order Code: H083 FL800010-FL800020; FLY00001-FLY00007.

Distribution pattern

U.S. Distribution to states of: CA, FL, GA, IL, WA.; and internationally to: Canada.

device · product 4 of 8

Surgical Handpiece, Model: SGA-E2G Order Code: H184, 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.

Z-0222-2019
Recall number
Z-0222-2019
Initiated
June 01, 2018
Classification
Class II
Status
Terminated
Recalling firm
Nakanishi Inc.
Quantity
6

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Previous Operation Manual: OM-H0035E001 Model Name: SGA-E2G Order Code: H184 Serial Nos. BL600026 - BL600031

Distribution pattern

U.S. Distribution to states of: CA, FL, GA, IL, WA.; and internationally to: Canada.

device · product 5 of 8

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.

Z-0223-2019
Recall number
Z-0223-2019
Initiated
June 01, 2018
Classification
Class II
Status
Terminated
Recalling firm
Nakanishi Inc.
Quantity
2419

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Previous Operation Manuals: OM-SH0015E002,OM-SH0015E003, OM-SH0015E004, OM-SH0015E005, OM-SH0100F, OM-SH0096S Model Name: SGS-ES; Order Code H264/H264007 Serial Nos.:0LZ00063 - 0LZ00064, 0LZ00066 - 0LZ00068, 0LZ00070 - 0LZ00109; 0LZ00110 - 0LZ00115; 0BB20112 -0BB20116, 0BB20226 - 0BB20229, 0BB40071 - 0BB40075, 0BB50186 - 0BB50189, 0BB50215 - 0BB50224, 0BB50263, 0BB50265, 0BB50266, 0BB50185, 0BB50190 - 0BB50192; 0BB60051 - 0BB60055, 0BB60079 - 0BB60100, 0BB60106 -0BB60118, 0BB70066 - 0BB70100, 0BB90004 - 0BB90058, 0BB90123 - 0BB90132, 0BBX0168 - 0BBX0175;0BBY0188 -0BBY0192; 0BC10095 - 0BC10099, 0BC10101 - 0BC10110, 0BC10121 - 0BC10130, 0BC10169 - 0BC10170, 0BC10176- 0BC10179, 0BC50093 - 0BC50102, 0BC60001 - 0BC60040, 0BC60085 - 0BC60104, 0BC60078 - 0BC60081, 0BC90001 - 0BC90090; 0BCY0003 - 0BCY0032; 0BD40011 -0BD40020, 0BD60001 - 0BD60034, 0BD60008 - 0BD60010, 0BD60016, 0BD60142-0BD60150, 0BD70062-0BD70072, 0BD80001 -0BD80034, 0BD80095 - 0BD80100, 0BDX0021 -0BDX0040, 0BDX0084- 0BDX0093; 0BDY0001- 0BDY0068, ABE10092 - ABE10121, ABE30001 - ABE30068, ABE30079 - ABE30088, ABE 60001- ABE60068, ABE 60056-ABE60065, ABE60005, ABE60011-ABE60015, ABE60030, ABE60136 - ABE60145, ABE70051- ABE70056, ABE90099-ABE90100; ABEX0001- ABEX0008; ABEY0052 - ABEY0071, ABEX0141 - ABEX0149; ABEY0011 - ABEY0020, ABEY0051; ABF10011- ABF10030, ABF20050, ABF20071 - ABF20079, ABF30014 - ABF30033, ABF70161 - ABF70166; ABFX0046 - ABFX0051, ABFX0053, ABFX0063, ABFY0031 -ABFY0033, ABFY0038- ABFY0040, ABFZ0043-ABFZ0062, ABFY0121 - ABFY0130; ABFZ0001 - ABFZ0040;ABG60147- ABG60154, ABG60156, ABG60159 - ABG60166; ABG70011- ABG70018, ABG70039 - ABG70048, ABG70059 -ABG70090; ABH50001 - ABH50009, ABH50010- ABH50400; ABH40106 - ABH40115; ABH60128 - ABH60137; ABH70001 - ABH70505; ABH80329- ABH80338; ABHX0001 - ABHX0343 - ;

Distribution pattern

U.S. Distribution to states of: CA, FL, GA, IL, WA.; and internationally to: Canada.

device · product 6 of 8

Micro Surgery Handpiece SGS, Model: SGS-E2S, Order Code: H266, 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..

Z-0224-2019
Recall number
Z-0224-2019
Initiated
June 01, 2018
Classification
Class II
Status
Terminated
Recalling firm
Nakanishi Inc.
Quantity
1662

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Previous Operation Manuals:OM-SH0015E002, OM-SH0015E003,OM-SH0015E004, OM-SH0015E005, OM-SH0100F,OM-SH0096S. Model Name: SGS-E2S; Order Code H266 Serial Nos.:0LZ00004 -0LZ00013, 0LZ00015- 0LZ00018, 0LZ00021 - 0LZ00030, 0LZ00036 - 0LZ00040, 0LZ00043- 0LZ00054 ; 0BB30001-0BB30010, 0BB30012 - 0BB30015; 0LZ00058; 0BB30022 - 0BB30026; 0BB50001-0BB50013, 0BB50021 - 0BB50025; 0BB70003 - 0BB70015; 0BB90007-0BB90027; 0BBX0001 - 0BBX0010; 0BBY0001 - 0BBY0027, 0BBY0031 - 0BBY0035; 0BBZ0017 - 0BBZ0026, 0BBZ0035 - 0BBZ0050; 0BC30001 - 0BC30004; 0BBZ0002 - 0BBZ0008; 0BC30008 - 0BC30020; 0BC50001 - 0BC50010; 0BC60001- 0BC60004, 0BC60006 - 0BC60031, 0BC60036 - 0BC60050; 0BC70001 - 0BC70015; 0BC90006 - 0BC90025, 0BC90031 - 0BC90050, 0BC90054 -0BC90060 - 0BC90080; 0BCX0001-0BCX0023; 0BCY0003 - 0BCY0027; 0BD10012 - 0BD10020; 0BD30001- 0BD30003, 0BD30006, 0BD30010- 0BD30018, 0BD10021 - 0BD10030; 0BD30028- 0BD30037; 0BD60021 - 0BD60030; 0BD60004 - 0BD60020, 0BD60031 - 0BD60033, 0BD60048 - 0BD60050; 0BD80001 - 0BD80017, 0BD80023 - 0BD80042, 0BBX0011, 0BBX0013, 0BBX0016 - 18, 0BBX0020; 0BD80047 - 0BD80050; ABDZ0001 - ABDZ0020; ABDZ0071 - ABDZ0080; ABDZ0027- ABDZ0070, ABDZ0081- ABDZ0086; ABE10023 - ABE10062; ABE 20008- ABE20026, ABE20028, ABE20036-ABE20055, ABE20065 - ABE20100; ABE50001 - ABE50004, ABE50019-ABE50058, ABE50080 - ABE50100; ABE90010 - ABE90050; ABEY0001-ABEY0012; ABEY0033- ABEY0052, ABEY0081- ABEY0100; ABF40001 - ABF40010, ABF40039- ABF40068, ABF40073 -ABF40092; ABF50020 - ABF50034; ABF60001 - ABF60015; ABFX0001 - ABFX0030, ABFX0042- ABFX0050; ABFY0001 , ABFY0013 - ABFY0052; ABFZ0049 - ABFZ0050; ABG20001 - ABG20018, ABG20026 - ABG20030; ABG30019-ABG30038; ABG60084 -ABG60113; ABG80003 - ABG80015; ABG80026- ABG80035; ABG80056-ABG80062; ABG60153- ABG60161; ABG80001, ABG80016- ABG80025; ABG80036 - ABG80055; ABG80066 - ABG80085, ABG80110- ABG80115; ABG90001 - ABG90019; ABG90038 - ABG90040; ABGX0001-ABGX0017, ABGX0029, ABGX0030, ABGZ0001- ABGZ0010; ABGZ0022 -ABGZ0051, ABGZ0055-ABGZ0060; ABH10001 - ABH10014; ABH20003 - ABH20030; ABH30001, ABH30002; ABH40032- ABH40035; ABH50001 -ABH50073; ABH60001-ABH60143; ABH60156- ABH60200; ABH70001-ABH70005, ABH70022 - ABH70051; ABH80002-ABH80032. - ;

Distribution pattern

U.S. Distribution to states of: CA, FL, GA, IL, WA.; and internationally to: Canada.

device · product 7 of 8

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.

Z-0225-2019
Recall number
Z-0225-2019
Initiated
June 01, 2018
Classification
Class II
Status
Terminated
Recalling firm
Nakanishi Inc.
Quantity
440

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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.

Distribution pattern

U.S. Distribution to states of: CA, FL, GA, IL, WA.; and internationally to: Canada.

device · product 8 of 8

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.

Z-0226-2019
Recall number
Z-0226-2019
Initiated
June 01, 2018
Classification
Class II
Status
Terminated
Recalling firm
Nakanishi Inc.
Quantity
1878

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Previous Operation Manuals: OM-SH0015E002, OM-SH0015E003, OM-SH0015E004, OM-SH0015E005, OM-SH0100F, OM-SH0096S. Model name: SGA-E2S Order Code: H265 ABB10001-ABB10028, ABB10031-ABB10078, ABB20002, ABB20016, ABB20023- ABB20044, ABB30001- ABB30015, ABB30021-ABB30053, ABB40001-ABB40012, ABB40023-ABB40025, ABB50001-ABB50022, ABB50029-ABB50049; ABB60001, ABB60041-ABB60050, ABB60052-ABB60054, ALZ00064-ALZ00073;ABB10028, ABB10031-ABB10078, ABB20002, ABB20016, ABB20023-ABB20044;ABB30001-ABB30015,ABB30021-ABB30053;ABB40001-ABB40012, ABB40023-ABB40025;ABB50001-ABB50022, ABB50029-ABB50049; ABB60001, ABB60018-ABB60025, ABB60026-ABB60050, ABB60052-ABB60068, ABB60075-ABB60101; ABB90001-ABB90017, ABB90023-ABB90032, ABB90034-ABB90050, ABBX0001-ABBX0008, ABBX0011-ABBX0025, ABBX0032-ABBX0046;ABBZ0009-ABBZ0023;ABBY0012, ABBY0015-ABBY0018, ABBY0041-ABBY0050; ABBZ0029-ABBZ0050; ABC20001-ABC20008, ABC20024-ABC20050;ABC30001-ABC30043, ABC30049-ABC30050; ABC50001-ABC50010; ABC60001-ABC60043, ABC60053-ABC60092, ABC60095-ABC60100;ABC70001-ABC70034, ABC70043-ABC70092; ABC90005-ABC90114, ABC90119-ABC90149;ABCX0001-ABCX0019,ABCX0044-ABCX0100; ABCY0001-ABCY0003; ABCY0032-ABCY0041; ABD20003-ABD20007; ABD10031-ABD10050, ABD10018-ABD10030; ABD50001-ABD50017, ABD50047-ABD50050; ABD90001- ABD90036; BBDZ0001, BBDZ0004, BBDZ0005, BBDZ0033-BBDZ0043, BBE10001-BBE10009,BBE10024-BBE10030, BBE10041-BBE10050, BBE20001-BBE20013;BBE40001-BBE40050; BBE50002-BBE50011, BBE50032-BBE50050;BBE70001,BBE70004-BBE70023-BBE70043, BBE70048-BBE70050;BBE90001-BBE90050;BBEX0001-BBEX0022; BBEX0039-BBEX0058; BBEX0087-BBEX0100; BBF30001-BBF30016;BBF30032-BBF30050; BBF40001, BBF40025-BBF40038; BBF50001-BBF50036, BBF50061, BBF50062, BBF60001-BBF60028;BBFZ0026-BBFZ0065, BBFZ0068-BBFZ0070;BBG10001-BBG10017;BBG30015-BBG30054, BBG30061-BBG30063; BBG60028-BBG60040; BBG70001-BBG70027;BBG80033-BBG80042, BBG80054- BBG80073; BBG80092-BBG80115; BBG90001-BBG90016; BBGX0006-BBGX0035;BBGY0013-BBGY0024;BBGY0054- BBGY0060; BBH10001-BBH10023;BBH10088-BBH10100; BBH20001-BBH20010; BBH20021-BBH20027;BBH30005-BBH30011;BBH40001-BBH40028; BBH50001-BBH50005, BBH50039-BBH50058, BBH50086-BBH50089;BBH60001-BBH60046;BBH70007-BBH70026;BBH70041-BBH70055

Distribution pattern

U.S. Distribution to states of: CA, FL, GA, IL, WA.; and internationally to: Canada.