Pentax Video Colonoscope is intended to be used with a… recallZ-0636-2017 · Pentax of America Inc · initiated Aug 15, 2016
Class II Terminated All recalls posted in November 2016
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Pentax of America Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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).
FDA root cause category: Other
What the company is doing
Pentax sent as "Urgent Field Correction" and Field Correction Response Form dated August 15, 2016 to their affected customers.
Recall details
- Recall number
- Z-0636-2017
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Aug 15, 2016
- Posted by the FDA
- Nov 19, 2016
- Recalling firm
- Pentax of America Inc
- Quantity
- 5,090 (US) and 14,209 (OUS)
- Product code
- FDF
- FDA submissions
- K131855
- Distribution
- US Nationwide and Japan
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.
Code information (models, lots, serial numbers)
Model #'s EC-2990LI, EC-3490LI, EC-3490LK, EC-3490TLI, EC-3890LI, EC-3890LK and EC-3890TLK
Other devices under the same FDA submission
19 devices cleared under K131855 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- PENTAX EC34-i10LHoya Corporation · Colonoscope and accessories, flexible/rigid848 reports
- PENTAX EC-3490LiHoya Corporation · Colonoscope and accessories, flexible/rigid481 reports
- PENTAX EC38-i10LHoya Corporation · Colonoscope and accessories, flexible/rigid212 reports
- PENTAX EC38-i10LHoya Corporation · Colonoscope and accessories, flexible/rigid191 reports
- PENTAX EC-3890LiHoya Corporation · Colonoscope and accessories, flexible/rigid163 reports
- PENTAX EC-3490TLiHoya Corporation · Colonoscope and accessories, flexible/rigid73 reports
- PENTAX EC-3890LKHoya Corporation · Colonoscope and accessories, flexible/rigid62 reports
- PENTAX EC-3490LKHoya Corporation · Colonoscope and accessories, flexible/rigid42 reports
- PENTAX EC-3890TLKHoya Corporation · Colonoscope and accessories, flexible/rigid33 reports
- PENTAX EC-2990LiHoya Corporation · Colonoscope and accessories, flexible/rigid31 reports
- PENTAX EC-3890LZiHoya Corporation · Colonoscope and accessories, flexible/rigid14 reports
- PENTAX EC38-i10LHoya Corporation · Colonoscope and accessories, flexible/rigid8 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page