Recall of Stryker Suction Irrigation Tips (general purpose irrigation/aspiration units)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Stryker Australia Pty Ltd.

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 II
  • Event Initiated Date
  • Event Country
  • Event Source
  • Event Source URL
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    The pre-vacuum steam sterilisation temperature in the instructions for use (ifu part # 1000-400-100 rev. k) is incorrectly listed as 121 - 123 degrees centigrade, instead of the correct 132 - 133 degrees centigrade (ifu part # 1000-400-100 rev. l).
  • Action
    Stryker is correcting the Instructions For Use.


  • Model / Serial
    Stryker Suction Irrigation Tips (general purpose irrigation/aspiration units)Multiple product codes and lot numbersARTG Number: 142830
  • Manufacturer


  • Manufacturer Parent Company (2017)
  • Source