Recall of Device Recall Pentax Video Duodenoscope

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Pentax of America Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    duodenoscope and accessories, flexible/rigid - Product Code FDT
  • Reason
    Pentax initiated a field correction/safety alert for two (2) models of the video duodenoscope to determine how soiling may have occurred on the surface of the suction cylinder and under the distal cap during testing.
  • Action
    The firm, Pentax Medical, sent a "FIELD CORRECTION' letter dated January 17, 2017 to their affected customers via USPS Certified Mail. The letter described the product, problem and actions to be taken. The customers were instructed to immediately remove any affected product from use; follow product labeling; ensure all reprocessing personnel are knowledgeable and thoroughly trained on the instructions of Use for manual reprocessing of the devices; clean elevator recesses and follow all reprocessing instructions; and complete and return the FIELD CORRECTION RESPONSE FORM via a member of the PENTAX Service Department as part of an on-site-visit or Fax to: QA/RA Department at 201-799-4063 (alternate 201-391-4189) or a pdf copy to The firm will replace any affected product with its current generation model. If you have questions or request further information or assistance contact PENTAX Medical Customer Support at 1-800-431-5880 (8:30AM - 5:00PM, Monday-Friday, EST) or email:


  • Model / Serial
    Model Numbers: Ed-3490TK and ED-3270K
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Worldwide Distribution-US (Nationwide) including states of: AL, AZ, CA, CO, CT, DC, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NH, NJ, NV, NY, OH, OK, PA, PR, TN, TX, UT, VA, WA, WI, WV, WY;. and country of: CANADA.
  • Product Description
    Video Duodenoscope || These instruments are intended to provide optical visualization of (via a video monitor), and therapeutic access to, the biliary tract via the upper GI tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: esophagus, stomach, duodenum, common bile, hepatic and cystic ducts.
  • Manufacturer


  • Manufacturer Address
    Pentax of America Inc, 3 Paragon Dr, Montvale NJ 07645-1782
  • Manufacturer Parent Company (2017)
  • Source