The Recall Desk
HighFDA (Devices)·Z-2075-2016·Announced 2016-07-06

Pentax Sigmoidoscopes Recalled Due to Risk of Lodged Accessories

Pentax Medical Company is recalling 1,596 sigmoidoscopes 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 is classified as FDA Class II and involves a risk-of-harm product where injury has not yet been reported, which corresponds to a High severity score of 3.

Plain-English summary

Pentax Medical Company is recalling 1,596 units of sigmoidoscopes, including models FS-34V, ES-3831, ES-3870K, and ES-3840. These devices are intended to provide optical visualization and therapeutic access to the lower gastrointestinal tract in adult and pediatric patients.

The recall was initiated because the manufacturer became aware that operational and cleaning accessories, as well as therapeutic devices such as clips, stents, and balloons, can become lodged in the endoscope's instrument channel.

The affected units were distributed nationwide in the United States, including Puerto Rico, as well as internationally to Denmark and Guam. The source text does not specify instructions for consumers or healthcare providers regarding the next steps for this recall.

The recalled product

Product
Signmoidoscope Intended to provide optical visualization of, therapeutic access to, the Lower Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Large Bowel to the Sigmoid Colon. The instrument is introduced via the rectu
Manufacturer
Pentax Medical Company
Category
Medical Device — Endoscopes
Hazard
Affected units
1,596

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 (3)

  • Model #'s FS-34V
  • ES-3831
  • ES-3870K and ES-3840

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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