Z-0636-2017Class II

Pentax Video Colonoscope is intended to be used with a PENTAX video processor (including light source)...

Name: Z-0636-2017 Pentax Video Colonoscope is intended to be used with a PENTAX video processor (including light source)...
Creator: Pentax of America Inc
Published: 2016-08-15
License: https://open.fda.gov/license/

PENTAX of America, Inc. / initiated 2016-08-15 / Terminated / root cause: labeling and UDI

FDA source

Pentax of America Inc began a recall of Pentax Video Colonoscope is intended to be used with a PENTAX video processor (including light source), documentation equipment, Monitor, EndoTherapy Device... on 2016-08-15. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0636-2017
Classification: Class II
Status: Terminated
Initiated: 2016-08-15
Posted: 2016-11-19
Terminated: 2018-03-08
Recalling firm: PENTAX of America, Inc.
Product: 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 code: FDF Colonoscope And Accessories, Flexible/Rigid
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).
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Pentax sent as "Urgent Field Correction" and Field Correction Response Form dated August 15, 2016 to their affected customers.
Quantity in commerce: 5,090 (US) and 14,209 (OUS)
Distribution: US Nationwide and Japan
Product codes and lots: Model #'s EC-2990LI, EC-3490LI, EC-3490LK, EC-3490TLI, EC-3890LI, EC-3890LK and EC-3890TLK

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0636-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0636-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-30	2016-11-19

Product code FDF

K131855Class IIPentax Video Colonoscopes (Ec Family)Pentax Medical Company / cleared 2014-04-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)