Early Alert: Handy Solutions Neck & Shoulders Heating Pad Issue from Navajo Manufacturing Company

CDRH is issuing this Early Alert to notify the public of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available.

Affected Product

The FDA is aware that Navajo Manufacturing Company has issued a letter to affected customers recommending affected heating pads be removed from where they are used or sold.

Affected devices:

• Product Name: Handy Solutions Neck & Shoulders Heating Pad  
• Model: 25607
• UPC: 024291256076
• UDI: 00024291256076

What to Do

Users should immediately discontinue use of affected heating pads, cut the heating pad cord and dispose of the heating pad. 

On February 16, Navajo Manufacturing Company sent all affected customers a letter recommending the following actions:

• Immediately discontinue use of affected heating pads
• Cut the heating pad power cord and dispose of the heating pad
• The consumer will be contacted by the platform through which they purchased the heating pads to arrange a replacement from a different manufacturer

Check this web page for updates. The FDA is currently reviewing information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available.

Reason for Alert

Navajo Manufacturing Company stated that if the heating pad is folded while in use, the power density increases in the folded area causing excessive temperatures in that area. The device is unable to detect the higher temperature and does not automatically shut off when hazardous temperatures are reached. Users may notice a burning smell prior to the device overheating. This issue may cause burns to persons and/or melting or burning of surrounding property. 

As of March 10, Navajo Manufacturing Company has reported four serious injuries, and no deaths associated with this issue.

Device Use

A powered heating pad is an electrical device intended for medical purposes that provides dry heat therapy for body surfaces. It is capable of maintaining an elevated temperature during use. 

Contact Information

Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Navajo Manufacturing Company at 1-800-332-1088.

Unique Device Identifier (UDI)  

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.

• How do I recognize a UDI on a label?
• AccessGUDID database - Identify Your Medical Device
• Benefits of a UDI System

How do I report a problem?  

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.