The Recall Desk
HighFDA (Devices)·Z-2069-2016·Announced 2016-07-06

Pentax Confocal GI Scope Recall Due to Lodged Accessories

Pentax Medical is recalling 17 Confocal GI Scopes 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 risk-of-harm product (medical device) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Pentax Medical Company is recalling 17 units of the Confocal GI Scope, models EG-3870CIK and EC-3870CILK. The recall is due to a defect where operational/cleaning accessories and therapeutic devices, such as clips, stents, and balloons, can become lodged in the endoscope's instrument channel.

The affected devices were distributed nationwide in the United States, including Puerto Rico, as well as internationally to Denmark and Guam. The product is intended to provide optical visualization and therapeutic access to the gastrointestinal tract for adult and pediatric patients.

Consumers and healthcare providers should stop using the affected units and contact Pentax Medical Company for further instructions regarding the recall.

The recalled product

Product
Confocal GI Scope Intended to provide optical visualization of an therapeutic access to the Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Esophagus, Stomach and Duodenum, and Large Bowel to the Cecum. The instrument
Manufacturer
Pentax Medical Company
Category
Medical Device — Endoscope
Hazard
Affected units
17

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 (2)

  • Model #'s EG-3870CIK
  • EC-3870CILK

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 →

Related recalls

Same manufacturer · Pentax Medical Company

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Same hazard · lodged accessory

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