The Recall Desk
HighFDA (Devices)·Z-2077-2016·Announced 2016-07-06

Pentax Ultrasound Gastroscope Recall Due to Lodged Accessories

Pentax Medical Company is recalling ultrasound gastroscopes because operational and therapeutic accessories can become lodged in the instrument channel.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a risk of harm (lodged accessories) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Pentax Medical Company is recalling 819 units of Ultrasound Gastroscopes. The affected models include EG-3630U, EG-3630UR, EG-3670URK, EG-3830UT, EG-3870UTK, FG-34UX, FG-36UX, and FG-38UX. These devices are intended to provide optical and ultrasonic visualization and therapeutic access to the upper gastrointestinal tract in adult and pediatric patients.

The recall is being conducted because operational and cleaning accessories, as well as therapeutic devices such as clips, stents, and balloons, can become lodged in the endoscope's instrument channel. This issue affects the functionality and safety of the device during procedures.

The affected units were distributed worldwide, including nationwide in the United States (including Puerto Rico) and internationally to Denmark and Guam. Healthcare facilities and users should stop using the affected devices and contact Pentax Medical Company for instructions on how to proceed.

The recalled product

Product
Ultrasound Gastroscope Intended to provide optical visualization of, ultrasonic visualization of and therapeutic access to, the Upper Gastrointestinal Track including but not restricted to organs, tissues and subsystems: Esophagus, Stomach, Duodenum, Small Bowel and underlying a
Manufacturer
Pentax Medical Company
Category
Medical Device — Endoscopy
Hazard
Affected units
819

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (7)

  • Model #'s EG-3630U
  • EG-3630UR
  • EG-3670URK
  • EG-3830UT
  • EG-3870UTK
  • FG-34UX
  • FG-36UX and FG-38UX

Distribution

Distributed in 2 states:

Part of a larger recall action

This product is one of 16 recalled by Pentax Medical Company under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 16 products in this recall →

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