Events

Recall of Device Recall Brookstone Heated Body Bean

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Brookstone Company, Inc..

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
    63497
  • Event Risk Class
    Class 2
  • Event Number
    Z-0616-2013
  • Event Initiated Date
    2012-11-02
  • Event Date Posted
    2012-12-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-06-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114063
  • 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
  • Reason
    Additional warning statement to prevent burns to the skin.
  • Action
    Brookstone sent a "MEDICAL DEVICE CORRECTION" letter dated December 10, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Recall Information is on the website link from the homepage, www. Brookstone.com. Recall posted: http://www.brookstone.com/recall-information. Questions call Brookstone Customer Care at 800.846.3000 or visit any Brookstone Store.

Device

Device Recall Brookstone Heated Body Bean
  • Model / Serial
    All lot codes
  • Distribution
    Nationwide Distribution.
  • Product Description
    Brookstone Heated Body Bean, electrically heated || SKU numbers: 734863 (Blue), 734864 (Plum), 734865 (Red). || Brookstone 3 in 1 wrap ,SKU734397 (Brown). || The Products are liquid filled bean shaped pouches that are electrically heated and then detached from the charger prior to use.
  • Manufacturer
    Brookstone Company, Inc.

Manufacturer

Brookstone Company, Inc.
  • Manufacturer Address
    Brookstone Company, Inc., 1 Innovation Way, Merrimack NH 03054-4873
  • Manufacturer Parent Company (2017)
    Sanpower Group Co. Ltd.
  • Source
    USFDA