Recall events
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Event 82451
Event summary
Timeline bucket March 08, 2019
Product types Device
Classifications Class II
Statuses Terminated
Recalling firm wording Gyrus ACMI, 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
10 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 10
Olympus Diego Elite Console MDCONS 100
Z-1178-2019
Recall number Z-1178-2019
Initiated March 08, 2019
Classification Class II
Status Terminated
Quantity US: 107 consoles, OUS: 157 consoles
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Software design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1178-2019
Source locator 0001-device-recall-0001-of-0001.json.zip#results[38983]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
Code information Consoles containing software UIC version 2.3.9.0 and RTC version 00.01.23 US Serial Numbers: GB00197 GB02851 GB04383 GB00235 GB02878 GB04384 GB00238 GB02995 GB04386 GB00270 GB03000 GB04400 GB00278 GB03054 GB04401 GB00280 GB03171 GB04412 GB00870 GB03173 GB04414 GB00886 GB03201 GB04416 GB00917 GB03232 GB04417 GB00925 GB03431 GB04419 GB00937O GB03519 GB04420 GB00949 GB03675 GB04481 GB02173 GB03714 GB04482 GB02250 GB03717 GB04483 GB02263 GB03733 GB04484 GB02268 GB03746 GB04485 GB02289 GB03782 GB04486 GB02366 GB03790 GB04488 GB02368 GB03791 GB04489 GB02372 GB03793 GB04490 GB02381 GB03923 GB04491 GB02390 GB03941 GB04496 GB02406 GB03961 GB04497 GB02422 GB03966 GB04498 GB02442 GB04008 GB04503 GB02446 GB04022 GB04506 GB02453 GB04035 GB04507 GB02457 GB04041 GB04515 GB02507 GB04195 GB04516 GB02538 GB04212 GB04517 GB02539 GB04214 GB04534 GB02602 GB04241 GB04540 GB02613 GB04243 GB04592 GB02716 GB04246 GB02807 GB04315 GB02808 GB04338 GB04367 OUS: GB03672 GB02338 GB02414 GB02863 GB00205 GB02324 GB02719 GB02933 GB02955 GB03799 GB02172 GB02460 GB02204 GB00857 GB00907 GB02928 GB00876 GB02413 GB00850 GB00879 GB00852 GB02466 GB02584 GB00698 GB02580 GB00904 GB02924 GB02930 GB00844 GB03946 GB03747 GB03226 GB03550 GB02940 GB02582 GB03432 GB04013 GB00959 GB03983 GB02655 GB02694 GB02576 GB02704 GB02925 GB02193 GB02216 GB00180 GB04244 GB00206 GB00266 GB00837 GB02463 GB00267 GB00848 GB00873 GB00821 GB03007 GB02558 GB00822 GB03233 GB02480 GB02569 GB02833 GB02559 GB02563 GB02557 GB00833 GB00702 GB02560 GB02656 GB02658 GB03005 GB02565 GB02500 GB02573 GB03677 GB02561 GB04204 GB03819 GB03921 GB02805 GB02282 GB02594 GB03189 GB02593 GB03716 GB04023 GB02659 GB02861 GB00700 GB03043 GB02283 GB03045 GB02568 GB00830 GB02889 GB03162 GB02567 GB02511 GB03023 GB03530 GB02304 GB02461 GB02519 GB02465 GB02415 GB02308 GB02328 GB02518 GB02325 GB02313 GB02494 GB04347 GB00897 GB02336 GB02579 GB00919 GB02196 GB00964 GB02194 GB00269 GB00899 GB00969 GB02280 GB02443 GB02864 GB03522 GB02217 GB03984 GB03207 GB00854 GB02497 GB02445 GB02517 GB02326 GB02299 GB02316 GB02501 GB02299 GB02316 GB02501 GB03800 GB03956 GB04543 GB04531 GB04536 GB04538 GB04518 GB04519 GB04520 GB04492 GB04493 GB04494 GB04495 GB04411 GB04413 GB04487
Distribution pattern Nationwide Foreign: Germany,Japan, Singapore
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[28325]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 10
Diego Elite Turbinate Blades:Bipolar Blade, 2mm straight, standard, type A Part No BB2000SA
Z-1179-2019
Recall number Z-1179-2019
Initiated March 08, 2019
Classification Class II
Status Terminated
Quantity 502 OUS
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Software design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1179-2019
Source locator 0001-device-recall-0001-of-0001.json.zip#results[11162]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
Code information All lot numbers
Distribution pattern Nationwide Foreign: Germany,Japan, Singapore
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[28435]
FDA event record
· Exact recall-number query on openFDA
device · product 3 of 10
Diego Elite Turbinate Blades Bipolar Blade, 4mm straight, Part Number: BB4000SS
Z-1180-2019
Recall number Z-1180-2019
Initiated March 08, 2019
Classification Class II
Status Terminated
Quantity 1333
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Software design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1180-2019
Source locator 0001-device-recall-0001-of-0001.json.zip#results[34502]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
Code information All lot numbers
Distribution pattern Nationwide Foreign: Germany,Japan, Singapore
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[28471]
FDA event record
· Exact recall-number query on openFDA
device · product 4 of 10
Diego Elite Turbinate Blades Bipolar Blade, 4mm straight, Part No: BB4000SC
Z-1181-2019
Recall number Z-1181-2019
Initiated March 08, 2019
Classification Class II
Status Terminated
Quantity 82
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Software design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1181-2019
Source locator 0001-device-recall-0001-of-0001.json.zip#results[11169]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
Code information All lot numbers
Distribution pattern Nationwide Foreign: Germany,Japan, Singapore
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[28597]
FDA event record
· Exact recall-number query on openFDA
device · product 5 of 10
Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number:BB4040SS
Z-1182-2019
Recall number Z-1182-2019
Initiated March 08, 2019
Classification Class II
Status Terminated
Quantity 247
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Software design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1182-2019
Source locator 0001-device-recall-0001-of-0001.json.zip#results[21021]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
Code information All lot numbers
Distribution pattern Nationwide Foreign: Germany,Japan, Singapore
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[28017]
FDA event record
· Exact recall-number query on openFDA
device · product 6 of 10
Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040SC
Z-1183-2019
Recall number Z-1183-2019
Initiated March 08, 2019
Classification Class II
Status Terminated
Quantity 13
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Software design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1183-2019
Source locator 0001-device-recall-0001-of-0001.json.zip#results[56968]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
Code information All lot numbers
Distribution pattern Nationwide Foreign: Germany,Japan, Singapore
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[28465]
FDA event record
· Exact recall-number query on openFDA
device · product 7 of 10
Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XS
Z-1184-2019
Recall number Z-1184-2019
Initiated March 08, 2019
Classification Class II
Status Terminated
Quantity 193
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Software design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1184-2019
Source locator 0001-device-recall-0001-of-0001.json.zip#results[11166]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
Code information All lot numbers
Distribution pattern Nationwide Foreign: Germany,Japan, Singapore
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[28296]
FDA event record
· Exact recall-number query on openFDA
device · product 8 of 10
Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XC
Z-1185-2019
Recall number Z-1185-2019
Initiated March 08, 2019
Classification Class II
Status Terminated
Quantity 21
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Software design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1185-2019
Source locator 0001-device-recall-0001-of-0001.json.zip#results[56972]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
Code information All lot numbers
Distribution pattern Nationwide Foreign: Germany,Japan, Singapore
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[27976]
FDA event record
· Exact recall-number query on openFDA
device · product 9 of 10
Diego Elite Blades Monopolar, 4mm Straight, TIA Product Code:MB4000SS
Z-1186-2019
Recall number Z-1186-2019
Initiated March 08, 2019
Classification Class II
Status Terminated
Quantity 318
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Software design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1186-2019
Source locator 0001-device-recall-0001-of-0001.json.zip#results[11164]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
Code information All lot numbers
Distribution pattern Nationwide Foreign: Germany,Japan, Singapore
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[27988]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1187-2019
Initiated March 08, 2019
Classification Class II
Status Terminated
Quantity 161
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Software design
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1187-2019
Source locator 0001-device-recall-0001-of-0001.json.zip#results[11171]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
Code information All lot numbers
Distribution pattern Nationwide Foreign: Germany,Japan, Singapore
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[28468]
FDA event record
· Exact recall-number query on openFDA
