FDANovember 3, 2020device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

ga health

UPCs

048971069511161489710695111324897106951110

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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