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U.S. Department of Health and Human Services

Class 2 Device Recall Foot Choice Therapeutic Foot Massager

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 Class 2 Device Recall Foot Choice Therapeutic Foot Massagersee related information
Date Initiated by FirmAugust 07, 2006
Date PostedAugust 07, 2009
Recall Status1 Terminated 3 on October 13, 2010
Recall NumberZ-1697-2009
Recall Event ID 49148
Product Classification Foot Massager - Product Code ILY
ProductFoot Choice Therapeutic Foot Massager, Model Number YS-322. The device is a heated foot massager intended for over the counter use.
Code Information No Lot Code (All massagers manufactured and shipped between 11/04/2005 - 06/29/2006).
Recalling Firm/
Manufacturer		 Suarez Corporation Industries
7800 Whipple Ave Nw
Canton OH 44720
For Additional Information ContactJane Kochis
330-494-4282
Manufacturer Reason
for Recall		Complaints of product causing burns to consumers.
FDA Determined
Cause 2		Device Design
ActionOn 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.
Quantity in Commerce71,512 units
DistributionNationwide and Canada.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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