FDA Device Recall Z-1588-2026

Navajo Manufacturing Company · Denver, CO

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death. Distribution is nationwide and the recall remains in progress.

Device

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

Lot / serial / GTIN: UPC: 0-24291-25607-6, UDI-DI: 00024291256076

Quantity: 28,457

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.

Recall record

Recall number: Z-1588-2026
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: US Nationwide distribution in the states of CA, MS, FL, IN, LA, VA, TX.
Recall initiated: 2026-02-18
Classified by FDA Center: 2026-03-20
FDA published: 2026-04-01
Recalling firm: Navajo Manufacturing Company
Firm location: Denver, CO

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

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