According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stryker Endoscopy.

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 Date Posted
  • 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
    Endoscope and/or accessories - Product Code KOG
  • Reason
    The parameters provided in the laparoscopic manual instruments instructions for use (ifu 1000-401-070 revision g or prior) do not support the unwrapped gravity cycle and the ethylene oxide cycle sterilization methods.
  • Action
    Stryker Endoscopy sent an Urgent Device Correction letter dated November 17, 2014, to affected customers. The letter informed the customers of the potential hazards and actions required. Customers were instructed to discard any old Instructions for Use for their Laparoscopic Manual Instruments and Accessories. Download the new Instuctions for Use (IFU1000-401-070 Revision J) from the URL link below: Customers were instructed to complete and sign the enclosed "Acknowledgement of Receipt" form and email them to or fax to (408) 855-6314. Customers with questions were instructed to contact Stryker Endoscopy at 408-855-6238 or via email at For questions regarding this recall call 408-754-2000.


  • Model / Serial
    06CON06113 0816243/0817410 0913221/0817442 0913222/0817442 1015164/1014813 1015164/1015778 1016405/1016061 1016405/1016400 1016405/1016401 1113335/1113339 1213126/1114543 1213127/1114543 1213127/1213123 1214001/1313047 1313947/1313946 0817389/0817444 0913565/0913326 0915791/0915061 0915791/1013608 0915894/0915061 0915895/0915061 1014635/1015778 1015165/1013609 1015165/1015778 1015773/1015778 1015774/1015778 1015862/1016061 1016124/1016061 1016125/1016062 1016128/1016061 1016406/1016400 1016408/1016400 1016408/1016826 1016562/1016400 1113333/1016063 1113333/1113018 1113333/1113136 1113333/1113339 1115969/1115651 1116112/1115651 1116113/1115651 1116114/1115651 1116115/1115651 1116256/1115651 1213128/1213731 1213973/1213978 1213974/1213731 1213974/1213978
  • Device Class
  • Implanted device?
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to Algeria, Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Ecuador, France, Germany, Greece, Guam, Guatemala, India, Italy, Japan, Jordan, Kuwait, Latin America, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Venezuela.
  • Product Description
    PKG, BIPOLAR FORCEPS, FENESTRATED, 33CM, P/N 0250080123 || Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
  • Manufacturer


  • Manufacturer Address
    Stryker Endoscopy, 5900 Optical Ct, San Jose CA 95138-1400
  • Manufacturer Parent Company (2017)
  • Source