Pentax Medical Company: Medical Device Recall in 2016 - (Recall #: Z-2275-2016)

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 Product Usage: 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: August 3, 2016

Recall Number: Z-2275-2016

Event ID: 73985

Reason for Recall:

Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with this devices in the United States.

Status: Terminated

Product Quantity: 12,412 units

Code Information:

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

Distribution Pattern:

US Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated