The Recall Desk
HighFDA (Devices)·Z-2065-2016·Announced 2016-07-06

Pentax Medical Recalls Bronchoscopes Due to Lodged Accessories

Pentax Medical is recalling 4,195 bronchoscopes 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 is classified as FDA Class II. The hazard involves a mechanical defect where accessories can become lodged in the instrument channel, representing a risk of harm to patients during procedures, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Pentax Medical Company is recalling 4,195 units of bronchoscopes. The affected devices are intended to provide optical visualization and therapeutic access to the airway and bronchial tree. The recall covers specific models including the FB-10V, FB015BS, and EB-1975K series.

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 the endoscope's instrument channel. This defect could potentially interfere with the proper functioning of the device.

The affected bronchoscopes were distributed worldwide, including nationwide in the United States (including Puerto Rico) and internationally to Denmark and Guam. Healthcare providers and facilities should stop using the affected devices and contact Pentax Medical for further instructions on remediation or replacement.

The recalled product

Product
Bronchoscope Intended to provide optical visualization of and therapeutic access to the Airway and Bronchial Tree. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Nasal Passage, Trachea and Bronchial Tree. The instrument is introduced via the
Manufacturer
Pentax Medical Company
Category
Medical Device — Endoscopes
Hazard
Affected units
4,195

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 (17)

  • Model #'s FB-10V
  • FB015BS
  • FB-15P
  • FB-15RBS
  • FB-15V
  • FB-18BS
  • FB-18P
  • FB-18RBS
  • FB-18V
  • FB-19TV
  • FB-8V
  • EB--1530T3
  • EB-1170K
  • EB01570K
  • EB-1575K
  • EB-1970K
  • EB-1970-TK and EB-1975K

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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