Recall events
/
Event 86763
Event summary
Timeline bucket November 03, 2020
Product types Device
Classifications Class II
Statuses Terminated
Recalling firm wording GA HEALTH COMPANY LIMITED
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
11 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 11
STOPCON Disposable Valves Set-Single Use Single Use Valves Olympus R (Air-Water-/Suction-/ Biopsy-Valve) DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10229
Z-0639-2021
Recall number Z-0639-2021
Initiated November 03, 2020
Classification Class II
Status Terminated
Quantity 12,800 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0639-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[22243]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure
Code information Lot Numbers: 19121831, 20032007 Unit UDI: 04897106951093 Box UDI: 14897106951090 Carton Box UDI: 24897106951097
Distribution pattern US Nationwide distribution including in the states of IL,NY, NJ, WI, MI, MN, WI.
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[32669]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 11
STOPCON Disposable Valves Set-Single Use Valves (suction-/air-water-/biopsy-valve/auxiliary water connector) DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10229.1
Z-0640-2021
Recall number Z-0640-2021
Initiated November 03, 2020
Classification Class II
Status Terminated
Quantity 25,000 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0640-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[4586]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure
Code information Lot Numbers: 19121830, 20031604 Unit UDI: 04897106951109 Box UDI: 24897106951103 Carton Box UDI: 24897106951103
Distribution pattern US Nationwide distribution including in the states of IL,NY, NJ, WI, MI, MN, WI.
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[33084]
FDA event record
· Exact recall-number query on openFDA
device · product 3 of 11
STOPCON Disposable Endoscope Valves Set-Single Use Valves Olympus R (Air-Water-/Suction) DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10229.2
Z-0641-2021
Recall number Z-0641-2021
Initiated November 03, 2020
Classification Class II
Status Terminated
Quantity 11,000 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0641-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[33401]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure
Code information Lot Numbers: 19121829 Unit UDI: 04897106951116 Box UDI: 14897106951113 Cartoon Box UDI: 24897106951110
Distribution pattern US Nationwide distribution including in the states of IL,NY, NJ, WI, MI, MN, WI.
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[34845]
FDA event record
· Exact recall-number query on openFDA
device · product 4 of 11
STOPCON Suction Valve-Suction Valve for GI-Endoscope DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10232
Z-0642-2021
Recall number Z-0642-2021
Initiated November 03, 2020
Classification Class II
Status Terminated
Quantity 10,000
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0642-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[11380]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure
Code information Lot Numbers: 19121826 Unit UDI: 04897106951178 Box UDI: 14897106951175 Cartoon Box UDI: 24897106951172
Distribution pattern US Nationwide distribution including in the states of IL,NY, NJ, WI, MI, MN, WI.
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[32675]
FDA event record
· Exact recall-number query on openFDA
device · product 5 of 11
Andorate Disposable Endoscope Valves Set-Contains Air/Water Valve,Suction Valve and Biopsy Valve Product Code: GAR004
Z-0643-2021
Recall number Z-0643-2021
Initiated November 03, 2020
Classification Class II
Status Terminated
Quantity 6,470 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0643-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[4589]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure
Code information Lot Numbers: 20040201, 20081925, 19111119, 20021928, 20022682, 20022678, 20030406, 20032503 Unit UDI: 04897106950225 Box UDI: 14897106950222 Cartoon Box UDI: 24897106950229
Distribution pattern US Nationwide distribution including in the states of IL,NY, NJ, WI, MI, MN, WI.
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[33060]
FDA event record
· Exact recall-number query on openFDA
device · product 6 of 11
Andorate Disposable Endoscope Valves Set-Contains Suction, Air/Water, Biopsy Valves and Auxiliary Water Connector Product Code: GAR046
Z-0644-2021
Recall number Z-0644-2021
Initiated November 03, 2020
Classification Class II
Status Terminated
Quantity 93,700 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0644-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[16348]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure
Code information Lot Numbers: 20021025, 20052901, 19102223, 19110721, 19120903, 19120909, 20021046, 20022803, 20030407, 20030408, 20030922, 20030923, 20031802, 20061806 Unit UDI: 04897106950263 Box UDI: 14897106950260 Cartoon Box UDI: 24897106950267
Distribution pattern US Nationwide distribution including in the states of IL,NY, NJ, WI, MI, MN, WI.
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[35758]
FDA event record
· Exact recall-number query on openFDA
device · product 7 of 11
Andorate Disposable Endoscope Valves Set-5-piece Valve, Connector and Cleaning Adapter Kit for Olympus Product Code: GAR3846
Z-0645-2021
Recall number Z-0645-2021
Initiated November 03, 2020
Classification Class II
Status Terminated
Quantity 50 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0645-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[39578]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure
Code information Lot Numbers: 20031002 Unit UDI: 04897106952571 Box UDI: 14897106952578 Cartoon Box UDI: 24897106952575
Distribution pattern US Nationwide distribution including in the states of IL,NY, NJ, WI, MI, MN, WI.
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[33051]
FDA event record
· Exact recall-number query on openFDA
device · product 8 of 11
Bulldog Disposable Endoscope Valves Set-Air/Water Valve, Suction Valve, Biopsy Valve Manufactured for: Diversatek Healthcare 102 E.Keefe Ave. Milwaukee, WI 53212 USA Product Code: 1203-71
Z-0646-2021
Recall number Z-0646-2021
Initiated November 03, 2020
Classification Class II
Status Terminated
Quantity 20,000 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0646-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[11378]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure
Code information Lot Numbers: 20B10A Unit UDI: 0816734021330 Box UDI: 10816734021337 Cartoon Box UDI: 20816734021334
Distribution pattern US Nationwide distribution including in the states of IL,NY, NJ, WI, MI, MN, WI.
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[33071]
FDA event record
· Exact recall-number query on openFDA
device · product 9 of 11
Bulldog Disposable Endoscope Valves Set-Air/Water Valve, Suction Valve,Biopsy Valve,Auxiliary Water Jet Connector Diversatek Healthcare 102 E.Keefe Ave. Milwaukee,WI 53212 USA Product Code: 1203-72
Z-0647-2021
Recall number Z-0647-2021
Initiated November 03, 2020
Classification Class II
Status Terminated
Quantity 20,000 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0647-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[44915]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure
Code information Lot Numbers: 20B10B, 20G10A Unit UDI: 0816734021347 Box UDI: 10816734021344 Cartoon Box UDI: 20816734021341
Distribution pattern US Nationwide distribution including in the states of IL,NY, NJ, WI, MI, MN, WI.
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[32662]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0648-2021
Initiated November 03, 2020
Classification Class II
Status Terminated
Quantity 100,000 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0648-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[22241]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure
Code information Lot Numbers: 19122414, 20030401, 20030402 Unit UDI: 0810929040380 Box UDI: 10810929040387 Carton Box UDI: 20810929040384
Distribution pattern US Nationwide distribution including in the states of IL,NY, NJ, WI, MI, MN, WI.
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[32637]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0649-2021
Initiated November 03, 2020
Classification Class II
Status Terminated
Quantity 10,000 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Process control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0649-2021
Source locator 0001-device-recall-0001-of-0001.json.zip#results[44917]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure
Code information Lot Numbers: 19122419 Unit UDI: 0810929043732 Box UDI: 10810929043739 Carton Box UDI: 20810929041640
Distribution pattern US Nationwide distribution including in the states of IL,NY, NJ, WI, MI, MN, WI.
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[33952]
FDA event record
· Exact recall-number query on openFDA
