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FDAJuly 13, 2017device

Video Cystoscope models ECY-1570 and ECY-1570K

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

The hazard

The video cytoscopes lack 510(k) premarket notification clearance.

What to do

FDA enforcement status: Terminated

Brands named

pentax

Recall history

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

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