SHARPER IMAGE CWT05112Recalls & reported problems
Zhejiang Lumeng Health & Technology Co., Ltd. · CALMING HEAT WEIGHTED MASSAGING HEATING PAD · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 06973305010026), received between Sep 19, 2025 and Sep 19, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Scratched Material” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Scratched Material1
- Use of Device Problem1
Patient problems
- Partial thickness (Second Degree) Burn1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 19, 2025Use of Device Problem; Scratched Material; Use of Device Problem; Scratched Material
ON 29-AUG-2025, ALLSTAR MARKETING GROUP RECEIVED THE FOLLOWING REPORT REGARDING A 37-YEAR-OLD FEMALE CONSUMER IN ASSOCIATION WITH THE CALMING HEAT WEIGHTED HEATING PAD AND MASSAGE PAD. ON (B)(6) 2025, A FEW TIMES AFTER USING THE PRODUCT, THE CONSUMER PLUGGED THE PRODUCT IN AND APPLIED IT ACROSS HER STOMACH DURING HER CYCLE TO RELIEVE HER CRAMPS. AFTER APPROXIMATELY 10 MINUTES OF PRODUCT APPLICATION, SHE NOTICED THE FABRIC AREA WAS NOT WARM, BUT THE CONNECTOR WAS HOT. SHE UNPLUGGED THE CALMING HEAT WEIGHTED HEATING PAD AND MASSAGE PAD. LATER THAT DAY, THE SKIN ON HER RIGHT HIP WAS RED, BLISTERED, AND PAINFUL. SHE WENT TO AN EMERGENCY ROOM. SHE WAS TREATED WITH TYLENOL (ACETAMINOPHEN) WITH CODEINE FOR A SECOND-DEGREE BURN. SHE WAS TO APPLY NEOSPORIN TO THE AREA AND TO COVER WITH GAUZE. AT THE TIME OF THE REPORT, SHE EXPERIENCED PAIN AND HAD NOT WORKED FOR THREE DAYS.
Patient problems: Partial thickness (Second Degree) Burn
MAUDE report 23099879 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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