Events

Recall of Foot Choice Therapeutic Foot Massager

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Suarez Corporation Industries.

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
    49148
  • Event Risk Class
    Class 2
  • Event Number
    Z-1697-2009
  • Event Initiated Date
    2006-08-07
  • Event Date Posted
    2009-08-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-10-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73169
  • 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
    Foot Massager - Product Code ILY
  • Reason
    Complaints of product causing burns to consumers.
  • Action
    On August 9- August 14, 2006, the firm sent a letter to all customers which included an "Important Customer Reminder." The Reminder now listed additional warnings about serious burns occurring regardless of the control settings. Direct questions to Suarez Corporation Industries by calling 1-330-494-5504.

Device

Foot Choice Therapeutic Foot Massager
  • Model / Serial
    No Lot Code (All massagers manufactured and shipped between 11/04/2005 - 06/29/2006).
  • Product Classification
    Physical Medicine Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and Canada.
  • Product Description
    Foot Choice Therapeutic Foot Massager, Model Number YS-322. || The device is a heated foot massager intended for over the counter use.
  • Manufacturer
    Suarez Corporation Industries

Manufacturer

Suarez Corporation Industries
  • Manufacturer Address
    Suarez Corporation Industries, 7800 Whipple Ave Nw, Canton OH 44720
  • Manufacturer Parent Company (2017)
    Suarez Corporation Industries
  • Source
    USFDA