Events

Recall of Hello Kitty'', Plaque Removing Toothbrush, Model HK70W. Powered toothbrush.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Emerson Radio 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
    Recall
  • Event ID
    26147
  • Event Risk Class
    Class 2
  • Event Number
    Z-0847-03
  • Event Initiated Date
    2003-04-09
  • Event Date Posted
    2003-05-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-10-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27173
  • 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
    Toothbrush, Powered - Product Code JEQ
  • Reason
    Powered toothbrushes are exploding due to gas build-up.
  • Action
    Telephone calls were initiated on 4/9/2003 to Emerson''s customers by their sales personnel. Instructions were to remove from the store shelves and return to Emerson.

Device

Hello Kitty'', Plaque Removing Toothbrush, Model HK70W. Powered toothbrush.
  • Model / Serial
    Gimelli No: 7625.006; Emerson #: HK70W.
  • Product Classification
    Dental Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Product was distributed nationwide to primarily Target stores, Toys R Us and Kids R Us as well as a small number of retail establishments. NASCAR Model NC70 was only distributed to Target Stores.
  • Product Description
    Hello Kitty'', Plaque Removing Toothbrush, Model HK70W. Powered toothbrush.
  • Manufacturer
    Emerson Radio Corp.

Manufacturer

Emerson Radio Corp.
  • Manufacturer Address
    Emerson Radio Corp., 9 Entin Rd, Parsippany NJ 070540430
  • Source
    USFDA