Pentax Medical Company: Medical Device Recall in 2016 - (Recall #: Z-2066-2016)

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:

Choledocho-Nephroscope Intended to provide optical visualization of and therapeutic access to the Abdominal Cavity. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Biliary tree with access to the Common bile Duct, Hepatic Duct, Cystic Duct, Kidney, Renal Cavity and Renal Calyces. The instrument is introduced via percutaneous cut when indications consistent with the need for procedure are observed in adult and pediatric patient populations.

Product Classification:

Class II

Date Initiated: April 6, 2016

Date Posted: July 6, 2016

Recall Number: Z-2066-2016

Event ID: 73894

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.

Status: Terminated

Product Quantity: 126 units

Code Information:

Model #'s ECN-1530 and FCN-15X

Distribution Pattern:

Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam

Voluntary or Mandated:

Voluntary: Firm initiated