The Recall Desk

FDA (Devices) recall action 86763

GA HEALTH COMPANY LIMITED recalled 11 products on 2020-12-30

The FDA (Devices) publishes a recall like this one as 11 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 11 pages.

Products
11
Announced
2020-12-30
Critical
0
Units
309,020

Why these products were recalled

Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–11 of 11

  • HighFDA (Devices)··2020-12-30

    GA Health Company Recalls STOPCON Disposable Valves Due to Defects

    GA Health Company is recalling 12,800 units of STOPCON Disposable Valves because the suction button may be sticky or broken, potentially prolonging medical procedures.

    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
    Category
    Distribution
    7 states
  • HighFDA (Devices)··2020-12-30

    GA Health Recalls 10,000 STOPCON Suction Valves for GI Endoscopes

    GA Health Company Limited is recalling 10,000 STOPCON Suction Valves for GI endoscopes because the suction button is reported sticky or broken, which may cause prolonged procedures.

    Product
    STOPCON Suction Valve-Suction Valve for GI-Endoscope DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10232
    Category
    Distribution
    7 states
  • HighFDA (Devices)··2020-12-30

    GA Health Recalls Andorate Disposable Endoscope Valves Due to Defective Suction Button

    GA Health Company Limited is recalling Andorate Disposable Endoscope Valves because the suction button may be sticky or broken, potentially prolonging medical procedures.

    Product
    Andorate Disposable Endoscope Valves Set-Contains Air/Water Valve,Suction Valve and Biopsy Valve Product Code: GAR004
    Category
    Distribution
    7 states
  • ModerateFDA (Devices)··2020-12-30

    GA Health Recalls Andorate Disposable Endoscope Valves Due to Suction Button Defect

    GA Health Company Limited is recalling 50 units of Andorate Disposable Endoscope Valves because the suction button may be sticky or broken, potentially prolonging procedures.

    Product
    Andorate Disposable Endoscope Valves Set-5-piece Valve, Connector and Cleaning Adapter Kit for Olympus Product Code: GAR3846
    Category
    Distribution
    7 states
  • HighFDA (Devices)··2020-12-30

    GA Health Recalls ScopeValet Guardian Disposable Endoscope Valves Due to Defect

    GA Health Company Limited is recalling 10,000 ScopeValet Guardian Disposable Endoscope Valves because the suction button may be sticky or broken, potentially prolonging procedures.

    Product
    ScopeValet Guardian Disposable Endoscope Valves Set- Air/Water, Suction, Biopsy Valve, Auxiliary Water Connector Product Code: 345SVVO4
    Category
    Distribution
    7 states
  • HighFDA (Devices)··2020-12-30

    GA Health Company Recalls Bulldog Disposable Endoscope Valves Due to Defects

    GA Health Company is recalling 20,000 units of Bulldog Disposable Endoscope Valves because the suction button may be sticky or broken, potentially prolonging medical procedures.

    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
    Category
    Distribution
    7 states
  • HighFDA (Devices)··2020-12-30

    GA Health Company Recalls Bulldog Disposable Endoscope Valves Due to Defects

    GA Health Company is recalling 20,000 units of Bulldog Disposable Endoscope Valves because the suction button is reported sticky or broken, which may cause prolonged procedures.

    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
    Category
    Distribution
    7 states
  • HighFDA (Devices)··2020-12-30

    GA Health ScopeValet Guardian Disposable Endoscope Valves Recalled for Defects

    GA Health Company Limited is recalling ScopeValet Guardian Disposable Endoscope Valves because the suction button may be sticky or broken, potentially prolonging procedures.

    Product
    ScopeValet Guardian Disposable Endoscope Valves Set Distributed By Ruhof Corporation, 393 Sagamore Avenue, Mineola, NY 11501 Product Code: 345SVVO1
    Category
    Distribution
    7 states
  • HighFDA (Devices)··2020-12-30

    GA Health Recalls 11,000 Stopcon Disposable Endoscope Valve Sets

    GA Health Company Limited is recalling 11,000 Stopcon Disposable Endoscope Valve Sets because the suction button may be sticky or broken, potentially prolonging medical procedures.

    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
    Category
    Distribution
    7 states
  • HighFDA (Devices)··2020-12-30

    GA Health STOPCON Disposable Valves Recalled for Sticky or Broken Suction Buttons

    GA Health Company Limited is recalling 25,000 units of STOPCON Disposable Valves because the suction button may be sticky or broken, potentially prolonging procedures.

    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
    Category
    Distribution
    7 states
  • HighFDA (Devices)··2020-12-30

    GA Health Recalls Andorate Disposable Endoscope Valves Due to Defective Suction Button

    GA Health Company Limited is recalling 93,700 units of Andorate Disposable Endoscope Valves because the suction button may be sticky or broken, potentially prolonging medical procedures.

    Product
    Andorate Disposable Endoscope Valves Set-Contains Suction, Air/Water, Biopsy Valves and Auxiliary Water Connector Product Code: GAR046
    Category
    Distribution
    7 states