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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

GA HEALTH COMPANY LIMITED: Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure

Agency Publication Date: December 18, 2020
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Affected Products

Product: 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

Lot Numbers: 19121831, 20032007 Unit UDI: 04897106951093 Box UDI: 14897106951090 Carton Box UDI: 24897106951097

Lot Numbers:
Numbers
Product: 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

Lot Numbers: 19121830, 20031604 Unit UDI: 04897106951109 Box UDI: 24897106951103 Carton Box UDI: 24897106951103

Lot Numbers:
Numbers
Product: 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

Lot Numbers: 19121829 Unit UDI: 04897106951116 Box UDI: 14897106951113 Cartoon Box UDI: 24897106951110

Lot Numbers:
Numbers
Product: STOPCON Suction Valve-Suction Valve for GI-Endoscope DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10232

Lot Numbers: 19121826 Unit UDI: 04897106951178 Box UDI: 14897106951175 Cartoon Box UDI: 24897106951172

Lot Numbers:
Numbers
Product: Andorate Disposable Endoscope Valves Set-Contains Air/Water Valve,Suction Valve and Biopsy Valve Product Code: GAR004

Lot Numbers: 20040201, 20081925, 19111119, 20021928, 20022682, 20022678, 20030406, 20032503 Unit UDI: 04897106950225 Box UDI: 14897106950222 Cartoon Box UDI: 24897106950229

Lot Numbers:
Numbers
Product: Andorate Disposable Endoscope Valves Set-Contains Suction, Air/Water, Biopsy Valves and Auxiliary Water Connector Product Code: GAR046

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

Lot Numbers:
Numbers
Product: Andorate Disposable Endoscope Valves Set-5-piece Valve, Connector and Cleaning Adapter Kit for Olympus Product Code: GAR3846

Lot Numbers: 20031002 Unit UDI: 04897106952571 Box UDI: 14897106952578 Cartoon Box UDI: 24897106952575

Lot Numbers:
Numbers
Product: 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

Lot Numbers: 20B10A Unit UDI: 0816734021330 Box UDI: 10816734021337 Cartoon Box UDI: 20816734021334

Lot Numbers:
Numbers
Product: 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

Lot Numbers: 20B10B, 20G10A Unit UDI: 0816734021347 Box UDI: 10816734021344 Cartoon Box UDI: 20816734021341

Lot Numbers:
Numbers
Product: ScopeValet Guardian Disposable Endoscope Valves Set Distributed By Ruhof Corporation, 393 Sagamore Avenue, Mineola, NY 11501 Product Code: 345SVVO1

Lot Numbers: 19122414, 20030401, 20030402 Unit UDI: 0810929040380 Box UDI: 10810929040387 Carton Box UDI: 20810929040384

Lot Numbers:
Numbers
Product: ScopeValet Guardian Disposable Endoscope Valves Set- Air/Water, Suction, Biopsy Valve, Auxiliary Water Connector Product Code: 345SVVO4

Lot Numbers: 19122419 Unit UDI: 0810929043732 Box UDI: 10810929043739 Carton Box UDI: 20810929041640

Lot Numbers:
Numbers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 86763
Status: Resolved
Manufacturer: GA HEALTH COMPANY LIMITED
Manufactured In: Hong Kong SAR
Units Affected: 11 products (12,800 units; 25,000 units; 11,000 units; 10,000; 6,470 units; 93,700 units; 50 units; 20,000 units; 20,000 units; 100,000 units; 10,000 units)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.