Heating pad recalled as Class I because folding causes excessive temperatures
Navajo Manufacturing is recalling the Handy Solutions Neck & Shoulders Heating Pad because folding it during use raises power density in the folded area, causing excessive temperatures the limit device cannot sense.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The rubric states an FDA Class I recall is never scored below 4, and this record carries a Class I classification with no reported deaths in the source.
Plain-English summary
Navajo Manufacturing Company is recalling the Handy Solutions Neck & Shoulders Heating Pad, number 25607, made by Ninbo Unico Products Co., Ltd. About 28,457 units were distributed in California, Mississippi, Florida, Indiana, Louisiana, Virginia and Texas.
If the 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 the pad under the body. In that condition the high limit device is unable to sense the higher temperature, so power is not terminated. This may cause a burning smell prior to melting or burning, potentially causing burns to persons and property. The FDA has classified this recall as Class I, its most serious category.
Affected product carries UPC 0-24291-25607-6 and UDI-DI 00024291256076.
Consumers can identify affected product by the number and UPC above, and may contact Navajo Manufacturing Company for further information.
The recalled product
- Product
- Handy Solutions Neck & Shoulders Heating Pad, Number: 25607, Manufactured by Ninbo Unico Products Co., Ltd
- Manufacturer
- Navajo Manufacturing Company
- Category
- Medical Device — Heating pad
- Affected units
- 28,457
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UPC: 0-24291-25607-6
- UDI-DI: 00024291256076
Distribution
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