Recall of Device Recall Stryker Irrigator Reusable Tips

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
    Apparatus, suction, operating-room, wall vacuum powered - Product Code GCX
  • Reason
    The pre-vacuum steam sterilization (wrapped method) temperature in the instructions for use incorrectly listed 121-123¿c , instead of the correct 132-133¿c.
  • Action
    Stryker sent "Urgent Device Correction" letters dated March 27, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers.


  • Model / Serial
    Manufacturer Part Number: 250-070-473
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Worldwide Distribution: USA (nationwide) and countries of: Mexico, Portugal, Latin America, India, Greece, Taiwan, Singapore, New Zealand, Phillipines, Netherlands, France, Australia, Canada, Japan, Scandinavia, Iberia, Brasil, Romania, South Africa, Chile, Korea, China.
  • Product Description
    Stryker Irrigator Reusable Tips: || 2mm X 34cm Regular Tip with No Hole, Metal Finish. || Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
  • Manufacturer


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