Pentax of America Inc: Medical Device Recall in 2016 - (Recall #: Z-0318-2017)

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:

Pentax Video Gastroscope is intended to be used with a Pentax video processor (including light source), documentation equipment, monitor, EndoTherapy Device such as a Biopsy Forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the upper digestive tract including the esophagus, stomach and duodenum.

Product Classification:

Class II

Date Initiated: August 15, 2016

Date Posted: November 2, 2016

Recall Number: Z-0318-2017

Event ID: 75332

Reason for Recall:

PENTAX Medical is initiating this field action to provide customers that have purchased the affected endoscopes with the most recent Operation and Reprocessing IFUs.

Status: Terminated

Product Quantity: 3,436 (US) and 14,488 (OUS)

Code Information:

EG-1690K, EG-2490K, EG-279oI, EG-2790K, EG-2990K, EG-2990K, EG-349oK and EG-3890TK

Distribution Pattern:

US Nationwide and Japan

Voluntary or Mandated:

Voluntary: Firm initiated