Pentax Medical Company: Medical Device Recall in 2016 - (Recall #: Z-2067-2016)

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:

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 Classification:

Class II

Date Initiated: April 6, 2016

Date Posted: July 6, 2016

Recall Number: Z-2067-2016

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: 50 units

Code Information:

Model #'s FCP-8P and FCP-9P

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated