Recall of Coban 2 Compression Layer (active support bandage)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by 3M 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 manufacturer has advised that during printing an operator error occurred where the foil used as the primary packaging for coban 2 shows "coban 2 lite" as the product name. the compression bandage, the outer carton packaging, the corresponding instructions for use as well as the colour coding (purple for coban 2) are correct. if coban 2 is used (rather than coban 2 lite) for a patient requiring moderate compression, a reduced blood circulation in the extremity is a possible consequence. this could lead to local necrosis or complete ischemia of the lower leg.
  • Action
    3M Australia is advising users to inspect stock and quarantine the affected batch prior to returning to 3M.


  • Model / Serial
    Coban 2 Compression Layer (active support bandage)Product Code: 20024ID Number: DH888822474Lot Number: 2018-12AQExpiry Date: Dec 2018ARTG Number: 235181
  • Manufacturer


  • Manufacturer Parent Company (2017)
  • Source