Pentax Medical Company: Medical Device Recall in 2016 - (Recall #: Z-2068-2016)

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:

Colonoscope Intended to provide optical visualization of and therapeutic access to the Lower Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Large Bowel to the Cecum. 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-2068-2016

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: 12,412 units

Code Information:

Model #'s EC-3430L, EC-3430LK, EC-3470LK, EC-380LKP, EC-3830LK, EC-3930LZ, EC-3831L, EC-3832L, EC-3832LK, EC-3870LK, EC-3870LZK, EC-3872LK, FC-38LV, EC-3830TLK, EC-3832TL, EC-3870TLK, EC-3872TLK, EC-3440L, EC-3840K, EC-2990LI, EC-3490LI, EC-3490LK, EC-3490TLI, EC34-I10L, EC-3890LI, EC-3890LK, EC-3890TLK and EC38-I10L

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated