Pentax Medical Company: Medical Device Recall in 2014 - (Recall #: Z-2290-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

PENTAX Upper/Lower G.I. Endoscope OF-B130 and OF-B194 Gas/Water Feeding Valve

Product Classification:

Class II

Date Initiated: July 17, 2014

Date Posted: August 27, 2014

Recall Number: Z-2290-2014

Event ID: 68753

Reason for Recall:

The Instructions for Use for the Pentax OF-B130 and OF-B194 Gas/Water Valve IFU if not followed carefully may cause a potential risk to health.

Status: Terminated

Product Quantity: 98 units US; 1108 units OUS

Code Information:

Model No. OF-B130 OF-B194, all units.

Distribution Pattern:

Worldwide Distribution - US Distribution including the states of CA, CO, IN, KS and ID., and the countries of Asia, Canada, Europe and Japan.

Voluntary or Mandated:

Voluntary: Firm initiated