SoftHeat HP215V1Recalls & reported problems
Kaz USA, Inc. · Electric heating Pad MaxHeat by Softheat, 12" x 15", 3 heat settings, 60 minute auto shut-off. · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00328785000047), received between Jun 10, 2020 and Jun 10, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Use of Device Problem” (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.
Most reported problems
Device problems
- 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.
InjuryJun 10, 2020Use of Device Problem; Use of Device Problem
A CONSUMER STATED THAT HER HUSBAND HAD ALLEGEDLY RECEIVED 2ND DEGREE BURNS ON HIS BACK WHILE USING A HEATING PAD, AND MEDICAL ATTENTION WAS SOUGHT FOR HIS INJURY. THE CONSUMER STATED THAT HE WAS USING THE HEATING PAD IN BED AT THE TIME THAT THE INJURY OCCURRED. THE INSTRUCTIONS FOR PROPER USE CLEARLY STATE "DANGER: IF USED IMPROPERLY, THIS PRODUCT CAN CAUSE SEVERE BURNS TO SKIN, AND DAMAGE TO PROPERTY" AND "THIS HEATING PAD IS INTENDED FOR USE ON TOP OF YOUR BODY. DO NOT SIT OR LIE ON TOP OF THE HEATING PAD. NEVER PLACE PAD BETWEEN YOURSELF AND CHAIR, SOFA, BED OR PILLOW."
Patient problems: Partial thickness (Second Degree) Burn
MAUDE report 10137596 ↗
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- CONAIR HP01XFConair Corporation · Pad, Heating, Powered3 reports
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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