Z-2067-2016Class II

Choledochoscope Intended to provide optical visualization of and therapeutic access to the Biliary Tree. This...

Name: Z-2067-2016 Choledochoscope Intended to provide optical visualization of and therapeutic access to the Biliary Tree. This...
Creator: Pentax Medical Company
Published: 2016-04-06
License: https://open.fda.gov/license/

PENTAX of America, Inc. / initiated 2016-04-06 / Terminated / root cause: design

FDA source

Pentax Medical Company began a recall of Choledochoscope Intended to provide optical visualization of and therapeutic access to the Biliary Tree. This anatomy includes, but is not restricted to, the... on 2016-04-06. FDA classified it as Class II and gives the reason as "Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2067-2016
Classification: Class II
Status: Terminated
Initiated: 2016-04-06
Posted: 2016-06-28
Terminated: 2017-12-21
Recalling firm: PENTAX of America, Inc.
Product: Choledochoscope Intended to provide optical visualization of and therapeutic access to the Biliary Tree. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Common Bile, Hepatic, Cystic and Pancreatic Ducts. The instrument is introduced via the working channel of a Duodenoscope positioned for access to the Common bile Duct when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
Product code: FBN Choledochoscope And Accessories, Flexible/Rigid
Reason for recall: Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.
Root cause tag: design
FDA root cause: Device Design
Action: Pentax sent an Urgent Field Correction letter dated April 6, 2016 to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were reminded to carefully check that all accessories are intact, that no parts have fallen off and become lodged within the endoscope's instrument/suction channel and to ensure that any therapeutic devices passed through the instrument channel are accounted for after use. If the instrument/suction channel does become blocked or clogged due to the accumulation of debris, an accessory that cannot be removed, or other cause, do NOT attempt to correct the blockage or continue to use the endoscope. Customers were instructed to contact their local PENTAX Medical Service facility to have the endoscope repaired. Customers with questions were instructed to call 800-431-5880, ext 2064.
Quantity in commerce: 50 units
Distribution: Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam
Product codes and lots: Model #'s FCP-8P and FCP-9P

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2067-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2065-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-06	2016-06-28
Z-2066-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-06	2016-06-28
Z-2067-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-06	2016-06-28
Z-2068-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-06	2016-06-28
Z-2069-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-06	2016-06-28
Z-2070-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-06	2016-06-28
Z-2071-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-06	2016-06-28
Z-2072-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-06	2016-06-28
Z-2073-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-06	2016-06-28
Z-2074-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-06	2016-06-28
Z-2075-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-06	2016-06-28
Z-2076-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-06	2016-06-28
Z-2077-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-06	2016-06-28
Z-2078-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-06	2016-06-28
Z-2079-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-06	2016-06-28
Z-2080-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-06	2016-06-28

Product code FBN

K953286Class IIFcp-9P, Fiber CholedochoscopePentax Precision Instrument Corp. / cleared 1995-11-03

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)