Events

Recall of Device Recall Olympus Endoscopic Flushing Pump, Model OPF2

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Olympus 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
    Recall
  • Event ID
    65352
  • Event Risk Class
    Class 2
  • Event Number
    Z-0329-2014
  • Event Initiated Date
    2013-05-20
  • Event Date Posted
    2013-11-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-10-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118611
  • 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
    Pump, air, non-manual, for endoscope - Product Code FEQ
  • Reason
    There is a possibility that the pump head was not shipped in the locked position. if the pump head is in an unlocked position this may, under certain circumstances, cause the pump to stop and go into power stand-by mode.
  • Action
    Notification letters were sent to customers on May 20, 2013.

Device

Device Recall Olympus Endoscopic Flushing Pump, Model OPF2
  • Model / Serial
    Model OPF-2 with serial numbers: 21301567 21301799 21220870 21220876 21220878 21220869 21301569 21220788 21220710 21220712 21220181 21220707 21301315 21301216 21301672 21301675 21301793 21301795 21301960 21303157 21303159 21303161 21303388 21303390 21303391 21301064 21221126 21301053 21301059 21301570 21301573 21301054 21220701 21301066 21301203 21301205 21301209 21301673 21220706 21301572 21301052 21301055 21301065 21301571 21220953 21302798 21302917 21302920 21302925 21303009 21303017 21301058 21301060 21301485 21301493 21301566 21301408 21301961 21301804 21221123 21301317 21301483 21301217 21301320 21301482 21301214 21220357 21301062 21220179 21220171 21220789 21301487 21301489 21303156 21220877 21301413 21220176 21220711 21302919 21301796 21301797 21301415 21301963 21220174 21220168 21220704 21301056 21220621 21301204 21301207 21301212 21301215 21301575 21301206 21301213 21301321 21301322 21301406 21301484 21301568 21220709 21301409 21301404 21303162 21220790 21302791 21301414 21301407 21220785 21301410 21301210 21301211 21303010 21303014 21301411 21301577 21301208 21302921 21302923 21303013 21303397 21301316 21220868 21220787 21302910 21302911 21302912 21302915 21302918 21302974 21303012 21302913 21302922 21302924 21302973 21303008 21303015 21301490 21301492 21221124 21301957 21301959 21301965 21301966 21301967 21301968 21220169 21220951 21220963 21301313 21303016 21301798 21301486 21301488 21301491 21220615 21220618 21220625 21221125 21302914 21220871 21220880 21301405 21221122 21220175 21302916 21303158 21303160 21303387 21303392 21303393 21303396 21303398 21220180 21220708 21301674 21220702 21220616 21220623 21220783 21220793 21220178 21220613 21220620 21301962 21220865 21301958 21220260 21302971 21303389 21301061 21220872 21220875 21220879 21220952 21220954 21220955 21220956 21220957 21220958 21220959 21220960 21220961 21220962 21220964 21220965 21302792 21220172 21220866 21302972 21303011 21301794 21301800 21301802 21301803 21301319 21301412 21301574 21301801 21303394 21303395 21220624 21220791 21301318 21220703 21220263 21220614 21220786 21302793 21302794 21302789 21302796 21301576 21220170 21220262 21220358 21220705 21220713
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and the country of Canada.
  • Product Description
    Olympus Endoscopic Flushing Pump, Model OPF-2. || Facilitates washing of tissues to remove blood, feces and other organic matter during endoscopic procedures.
  • Manufacturer
    Olympus America Inc.

Manufacturer

Olympus America Inc.
  • Manufacturer Address
    Olympus America Inc., 3500 Corporate Pkwy., P.O. Box 610, Center Valley PA 18034-0610
  • Manufacturer Parent Company (2017)
    Olympus Corporation
  • Source
    USFDA