Recall of Device Recall Urovac

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

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
    unknown device name - Product Code KOG
  • Reason
    Sterility is compromised because the product is labeled as sterile, but the packages may have holes in them.
  • Action
    U.S. accounts were notified via recall letter dated 6/30/06 to cease use of the product and to return it to the firm. International accounts were also notified.


  • Model / Serial
    All lots expiring on or before June 12, 2010.
  • Device Class
  • Implanted device?
  • Distribution
    Nationwide and worldwide, including Argentina, Bangladesh, Belgium, Canada, Chile, China, Colombia, Dominican Republic, Egypt, El Salvador, Finland, France, Germany, Great Britain, Greece, Hong Kong, Ireland, Italy, Japan, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Philippines, Portugal, Romania, South Africa, Spain, Sri Lanka, Sweden, Tunisia, Turkey and Venezuela.
  • Product Description
    Boston Scientific Urovac Bladder Evacuator, sterile, single use only; REF/Catalog no. 730-125 and sold individually as UPN M0067301250 and in packaged of ten as UPN M0067301251.
  • Manufacturer


  • Manufacturer Address
    Boston Scientific Corp, 780 Brookside Dr, Spencer IN 47460-1080
  • Source