Pentax of America Inc: Medical Device Recall in 2016 - (Recall #: Z-0636-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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 anus, rectum, sigmoid colon, colon and ileocecal valve.

Product Classification:

Class II

Date Initiated: August 15, 2016

Date Posted: November 30, 2016

Recall Number: Z-0636-2017

Event ID: 75306

Reason for Recall:

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).

Status: Terminated

Product Quantity: 5,090 (US) and 14,209 (OUS)

Code Information:

Model #'s EC-2990LI, EC-3490LI, EC-3490LK, EC-3490TLI, EC-3890LI, EC-3890LK and EC-3890TLK

Distribution Pattern:

US Nationwide and Japan

Voluntary or Mandated:

Voluntary: Firm initiated