Pentax Medical Company: Medical Device Recall in 2013 - (Recall #: Z-0084-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

PENTAX Endoscopic Accessories. OF-B194. Made in Japan. PENTAX Upper/Lower G.I. Endoscopes are provided with Air/Water Valve. As an alternative, the optionally available Gas/Water Valve may be used in place of the standard Air/Water Valve to deliver a non-explosive gas for insufflation.

Product Classification:

Class I

Date Initiated: September 16, 2013

Date Posted: November 6, 2013

Recall Number: Z-0084-2014

Event ID: 66379

Reason for Recall:

PENTAX Medical has become aware of a product issue associated with the OF-B194 Gas/Water Feeding Valve. A manufacturing defect may cause improper stoppage of CO2 gas during an endoscopic procedure with the potential for serious hazard to and/or user.

Status: Terminated

Product Quantity: 76 units

Code Information:

Model OF-B194

Distribution Pattern:

Nationwide Distribution including Arizona, California, Florida, Idaho, Indiana, Kansas, Maryland, Missouri, Missippi, North Carolina, New York, Pennsylvania, Virginia, Wisconsin and Wyoming.

Voluntary or Mandated:

Voluntary: Firm initiated