Pentax Medical Company: Medical Device Recall in 2016 - (Recall #: Z-2276-2016)

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:

Confocal GI Scope Product Usage: Intended to provide optical visualization of and therapeutic access to the Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, and Large Bowel to the Cecum. The instrument is introduced via the mouth or rectum as decided by the the anatomy being accessed 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-2276-2016

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: 17 units

Code Information:

Model #'s EG-3870CIK and EC-3870CIK

Distribution Pattern:

US Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated