Changeflow GovPing Healthcare Handy Solutions Heating Pad Recall - Burn Hazard
Urgent Enforcement Removed Final

Handy Solutions Heating Pad Recall - Burn Hazard

Favicon for changeflow.com FDA: Device Recalls Class I
Filed April 1st, 2026
Detected April 7th, 2026
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Summary

The FDA issued a Class I recall for 847 Handy Solutions Neck & Shoulders Heating Pads (Number: 25607) manufactured by Ninbo Unico Products Co., Ltd and distributed by Navajo Manufacturing Company. The recall was initiated due to a burn hazard where folding the pad during use causes power density to increase beyond the high limit device's sensing capability, preventing automatic power termination. Distribution was nationwide across California, Mississippi, Florida, Indiana, Louisiana, Virginia, and Texas.

What changed

Navajo Manufacturing Company initiated a Class I device recall (Z-1588-2026) for 847 Handy Solutions Neck & Shoulders Heating Pads due to a serious burn hazard. When the heating pad is folded during use or placed under the body, the power density in the folded area increases excessively. The high limit safety device cannot sense the localized higher temperature and therefore does not terminate power, creating a risk of burns and fire.

Consumers who own this product should stop using it immediately and check whether their unit (Number: 25607) is affected by the recall. Healthcare providers should identify patients who may have purchased or received this device and advise them to discontinue use. Distributors and retailers should remove remaining inventory from shelves. The recall is classified as Class I, the most serious category, indicating reasonable probability of serious adverse health consequences or death.

What to do next

  1. Discontinue use of Handy Solutions Neck & Shoulders Heating Pad Number 25607 immediately
  2. Verify whether any inventory of the recalled product exists in stock and remove from distribution
  3. Notify affected customers or patients who may have received this device about the burn hazard and recall

Source document (simplified)

Navajo Manufacturing Company

Device Recalls (Class I)

← All Device Recalls (Class I) Class I Z-1588-2026 · 20260401 · Ongoing

Product

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

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 ...

Distribution

US Nationwide distribution in the states of CA, MS, FL, IN, LA, VA, TX.

Source: openFDA Enforcement API

Source

Analysis generated by AI. Source diff and links are from the original.

Classification

Agency
FDA
Filed
April 1st, 2026
Instrument
Enforcement
Legal weight
Binding
Stage
Final
Change scope
Substantive
Document ID
Z-1588-2026

Who this affects

Applies to
Medical device makers Consumers
Industry sector
3345 Medical Device Manufacturing
Activity scope
Medical Device Recall Product Safety Reporting
Geographic scope
United States US

Taxonomy

Primary area
Medical Devices
Operational domain
Compliance
Topics
Consumer Protection Product Safety

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