The Recall Desk
HighFDA (Devices)·Z-2071-2016·Announced 2016-07-06

Pentax Recalls 9,669 Gastroscope Units Due to Lodged Accessories

Pentax Medical is recalling 9,669 gastroscope units because operational or 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 is classified as FDA Class II and involves a risk-of-harm product where injury has not yet been reported, meeting the criteria for a High severity score.

Plain-English summary

Pentax Medical Company is recalling 9,669 units of its Gastroscope products. The affected models include FG-16V, FG-24V, FG-29V, EG-1540, EG-1580K, EG1840, EG-2540, EG-2940, EG-3840T, EG-3831T, EG-3870TK, EG-1870K, EG-2470K, EG-2530, EG-2730K, EG-2731, EG-2770K, EG-290KP, EG-2930K, EG-2931, EG-2931K, EG-2970K, EG-3430Z, EG-3470K, EG-3470ZK, EG-1690K, EG-2490K, EG-2790I, EG-2790K, EG27-I10, EG-2990I, EG-2990K, EG29-I10, EG-3490K, and EG-3890TK. These devices are intended to provide optical visualization of and therapeutic access to the Upper Gastrointestinal Tract, including the esophagus, stomach, and duodenum, for adult and pediatric patients.

The recall was initiated because Pentax 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, and internationally to Denmark and Guam.

Healthcare facilities and users should contact Pentax Medical Company for further instructions on how to manage the recalled devices. The source text does not report any specific injuries or illnesses associated with this defect.

The recalled product

Product
Gastroscope Intended to provide optical visualization of and therapeutic access to the Upper Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Esophagus, Stomach and Duodenum. The instrument is introduced via the mouth w
Manufacturer
Pentax Medical Company
Category
Medical Device — Endoscopes
Hazard
Affected units
9,669

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 FG-16V
  • FG-24V
  • FG-29V
  • EG-1540
  • EG-1580K
  • EG1840
  • EG-2540
  • EG-2940
  • EG-3840T
  • EG-3831T
  • EG-3870TK
  • EG-1870K
  • EG-2470K
  • EG-2530
  • EG-2730K
  • EG-2731
  • EG-2770K
  • EG-290KP
  • EG-2930K
  • EG-2931

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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