Heating Pad Recall: Navajo Manufacturing Company Removes Handy Solutions Neck & Shoulders Heating Pad

This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. This recall is an updated Early Alert. The affected products and recommendations for what to do with the devices below have not changed.

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

Reason for Recall

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 1-800-525-5097.

Additional FDA Resources

1. FDA Enforcement Report 
2. CDRH Medical Device Recall Database 

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.

Timeline of Communication Updates