Pentax Medical Company: Medical Device Recall in 2016 - (Recall #: Z-2278-2016)

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:

Gastroscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Upper Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach and Duodenum. The instrument is introduced via the mouth 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-2278-2016

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: 10,074 units

Code Information:

Model #'s FG-16V, FG-24V, FG-29V, EE-1540, EE-1580K, EG-1540, EG-1580K, EG-1840, EG-2540, EG-2940, EG-3840T, EG-3831T, EG-3870TK, EG-1870K, EG-2470K, EG-2530, EG-2730K, EG-2731, EG-2770K, EG-290KP, EG-2930K, EG-2931, EG-2931K, EG-2970K, EG-3430Z, EG-3470K, EG-3470ZK, VSB-3430K, EG-1690K, EG-2490K, EG-2790I, EG-2790K, EG27-I10, EG-2990I, EG-2990K, EG29-I10, EG-3490K and EG-3890TK.

Distribution Pattern:

US Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated