The Recall Desk
HighFDA (Devices)·Z-2068-2016·Announced 2016-07-06

Pentax Medical Recalls Colonoscopes Due to Lodged Accessories

Pentax Medical is recalling 12,412 colonoscopes because operational and cleaning 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 medical device where accessories can become lodged in the instrument channel, but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity score.

Plain-English summary

Pentax Medical Company is recalling 12,412 units of colonoscopes. These devices are intended to provide optical visualization of and therapeutic access to the Lower Gastrointestinal Tract, including the Large Bowel to the Cecum. The instruments are introduced via the rectum for adult and pediatric patient populations.

The recall was initiated because Pentax has become aware that operational and cleaning accessories, as well as therapeutic devices such as clips, stents, and balloons, can become lodged in an endoscope's instrument channel. The affected models include EC-3430L, EC-3430LK, EC-3470LK, EC-380LKP, EC-3830LK, EC-3930LZ, EC-3831L, EC-3832L, EC-3832LK, EC-3870LK, EC-3870LZK, EC-3872LK, FC-38LV, EC-3830TLK, EC-3832TL, EC-3870TLK, EC-3872TLK, EC-3440L, EC-3840K, EC-2990LI, EC-3490LI, EC-3490LK, EC-3490TLI, EC34-I10L, EC-3890LI, EC-3890LK, EC-3890TLK, and EC38-I10L.

The affected units were distributed nationwide in the United States, including Puerto Rico, as well as internationally to Denmark and Guam. Healthcare facilities and users should contact Pentax Medical Company for further instructions on how to proceed with the recall.

The recalled product

Product
Colonoscope Intended to provide optical visualization of and therapeutic access to the Lower Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Large Bowel to the Cecum. The instrument is introduced via the rectum when in
Manufacturer
Pentax Medical Company
Category
Medical Device — Endoscopes
Hazard
Affected units
12,412

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 (20)

  • Model #'s EC-3430L
  • EC-3430LK
  • EC-3470LK
  • EC-380LKP
  • EC-3830LK
  • EC-3930LZ
  • EC-3831L
  • EC-3832L
  • EC-3832LK
  • EC-3870LK
  • EC-3870LZK
  • EC-3872LK
  • FC-38LV
  • EC-3830TLK
  • EC-3832TL
  • EC-3870TLK
  • EC-3872TLK
  • EC-3440L
  • EC-3840K
  • EC-2990LI

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

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Same hazard · lodged accessories

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