FDAAugust 15, 2016device

Pentax Video Colonoscope is intended to be used with a PENTAX video processor (including light source), documentation equipment, Monitor, EndoTherapy Device such as a Biopsy Forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the lower digestive tract including the ...

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

The hazard

Pentax is initiating the product correction of several model numbers of Pentax's Colonoscope that were shipped between the clearance date of April 2014 and September 2015 because they contain the operation and reprocessing IFU's that were in use prior to the 2014 clearances and therefore did not include the cleared operation IFU, the updated reprocessing IFU or the dedicated reprocessing adaptor (for applicable models).

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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