Navajo Manufacturing Company medical device recall: Handy Solutions Neck & Shoulders Heating Pad
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Medical devices
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 98453
- Recall initiated
- Feb 18, 2026
- Classified by FDA
- Mar 20, 2026
- Posted in Enforcement Report
- Apr 1, 2026
- Recalling firm
- Navajo Manufacturing Company
- Firm location
- Denver, CO, United States
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Letter
- Products in this event
- 1
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
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.
What the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on Feb 18, 2026. FDA classified it 30 days later, on Mar 20, 2026. Distribution reported by FDA: US Nationwide distribution in the states of CA, MS, FL, IN, LA, VA, TX.
Recalled products (1)
Z-1588-2026 Class I Ongoing
Handy Solutions Neck & Shoulders Heating Pad, Number: 25607, Manufactured by Ninbo Unico Products Co., Ltd
Codes / lots: UPC: 0-24291-25607-6, UDI-DI: 00024291256076
Quantity: 28,457
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
- Official notice
- FDA Enforcement Report, event 98453
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.