Pentax Medical Company: Medical Device Recall in 2016 - (Recall #: Z-2075-2016)

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:

Signmoidoscope Intended to provide optical visualization of, therapeutic access to, the Lower Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Large Bowel to the Sigmoid Colon. The instrument is introduced via the rectum 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-2075-2016

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: 1,596 units

Code Information:

Model #'s FS-34V, ES-3831, ES-3870K and ES-3840

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated