Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1588-2026Class I

Handy Solutions Neck & Shoulders Heating Pad, Number: 25607, Manufactured by Ninbo Unico Products Co., Ltd

Navajo Manufacturing Company / initiated 2026-02-18 / Open, Classified / root cause: design

Navajo Manufacturing Company began a recall of Handy Solutions Neck & Shoulders Heating Pad, Number: 25607, Manufactured by Ninbo Unico Products Co., Ltd on . FDA classified it as Class I and gives the reason as "If heating pad is folded while in use, the power density increases in the folded area causing excessive temperatures, which can also be caused by placing pad under the body, then the high limit device is unable to sense...". As of , the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number
Z-1588-2026
Classification
Class I
Status
Open, Classified
Initiated
Posted
Recalling firm
Navajo Manufacturing Company
Product
Handy Solutions Neck & Shoulders Heating Pad, Number: 25607, Manufactured by Ninbo Unico Products Co., Ltd
Product code
IRT Pad, Heating, Powered
Reason for recall
If heating pad is folded while in use, the power density increases in the folded area causing excessive temperatures, which can also be caused by placing pad under the body, then the high limit device is unable to sense the higher temperature so power is not terminated. May cause a burning smell prior to melting/burning potentially causing burns to persons and property.
Root cause tag
design
FDA root cause
Device Design
Action
On 2/18/2026 a recall notice was emailed to one customer who was asked to do the following: Begin processes for notifying your distributors/customers who were shipped affected devices. They should return all unsold units to the recalling firm. Your customers should begin to notify their customers as well to discontinue use of the product. A Consumer Recall Notice will be included as a separate file that can be provided to the consumer. Retailers should notify consumers who received the recalled heating pad to immediately discontinue use of the heating pad, cut the heating pad s cord, and dispose of the heating pad. Consumers should immediately discontinue use of the heating pad. The heating pad's cord should be cut and the heating pad disposed of. The consumer will be contacted by the platform through which they purchased the heating pads to arrange replacement from a different manufacturer. Complete and return the Acknowledgement and Receipt Form to [email protected] If you have questions, firm can be contacted via phone: 1-800-525-5097, or email: [email protected]
Quantity in commerce
28,457
Distribution
US Nationwide distribution in the states of CA, MS, FL, IN, LA, VA, TX.
Product codes and lots
UPC: 0-24291-25607-6, UDI-DI: 00024291256076

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1588-2026
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1588-2026Class IOngoingVoluntary: Firm initiated