FDA (Devices) recall action 86763
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.
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.
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.
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.
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.
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.
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.
GA Health Company Limited is recalling Andorate Disposable Endoscope Valves because the suction button may be sticky or broken, potentially prolonging medical procedures.
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.
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.
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.
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.
GA Health Company Limited is recalling ScopeValet Guardian Disposable Endoscope Valves because the suction button may be sticky or broken, potentially prolonging procedures.