HANDY SOLUTIONS HEATING PAD WRAP SHOULDER AND NECK 25607Recalls & reported problems
Navajo Manufacturing Company · A powered heating pad is an electrical device intended for medical purposes that provides dry heat therapy for body surfaces. It is capable of maintaining an elevated temperature during use. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Handy Solutions heating pad wrap for the shoulder and neck is described in 25 reports, mostly involving overheating, excessive heat, smoking or fire, burns, and damage to bedding or furniture. The reports mention 17 injuries and no deaths. One open recall began in February 2026 because folding the pad or placing it under the body can create excessive heat that the temperature limit may not detect; reports rose from 0 in the previous 12 months to 25 in the latest 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 25
- Deaths reported
- 0
- Injuries reported
- 17
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00024291256076), received between Feb 4, 2026 and Jun 3, 2026 — classified as 17 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Overheating of Device” (10 reports).
1 FDA recall record name this device's identifier, 1 still open.
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 18, 2026.
Reports received per month
Recalls naming this device
- Feb 18, 2026Class IOpen, Classified
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.
Z-1588-2026 · Root cause: Device Design · Recall details · FDA record ↗
Most reported problems
Device problems
- Overheating of Device10
- Temperature Problem8
- Excessive Heating3
- Fire3
- Adverse Event Without Identified Device or Use Problem1
- Patient Device Interaction Problem1
- Smoking1
Patient problems
- Insufficient Information15
- Burn(s)4
- No Clinical Signs, Symptoms or Conditions3
- Superficial (First Degree) Burn2
- Blister1
- Partial thickness (Second Degree) Burn1
- Scar Tissue1
- Unspecified Tissue Injury1
Recent adverse event reports
The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.
OtherJun 3, 2026Overheating of Device; Smoking
PATIENT DOES NOT RECALL EXACT DATE BUT REPORTS TAKING THIS HEATING PAD OUT OF THE BOX AROUND WHEN IT WAS DELIVERED TO HER ON (B)(6) 2025, PLUGGING IT INTO AN ELECTRICAL OUTLET AND LEAVING IT ON HER BED. SHE LEFT THE ROOM AND UPON RETURNING TO THE ROOM SHE NOTICED THAT IT WAS SMOKING AND HER IT HAD BURNED A HOLE IN HER BEDSHEET. SHE THEN DISCARDED OF THE HEATING PAD AND DID NOT REPORT ANY INJURIES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25381180 ↗OtherJun 3, 2026Overheating of Device
HEATING PAD OVERHEATED CAUSING BURNS/DAMAGE TO PROPERTY BUT PATIENT WAS NOT HARMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25381116 ↗MalfunctionMay 21, 2026Temperature Problem
HEATING PAD MADE BY VAVAJO MANUFACTURING COMPANY INC. OVERHEATED AND BURNED THROUGH THE FABRIC OF THE HEATING PAD. NO PATIENT INJURY.
Patient problems: Insufficient Information
MAUDE report 25250793 ↗MalfunctionMay 21, 2026Overheating of Device
PATIENT RECEIVED AN OVER THE COUNTER HEATING PAD THAT LATER WAS RECALLED. PATIENT STATES THE HEATING PAD FELT VERY HOT ON HER NECK WHILE IN USE. PATIENT LEFT HEATING PAD ON HER CHAIR/RECLINER WHILE USING THE RESTROOM. WHEN PATIENT RETURNED,THE HEATING PAD HAD MELTED THE CHAIR.
Patient problems: Insufficient Information
MAUDE report 25250779 ↗InjuryMay 21, 2026Temperature Problem
PATIENT CALLED TO REPORT RECEIVING LETTER ADVISING OF OVERHEATING ISSUE WITH HEATING PAD (OTC#448) PURCHASED FROM PHARMACY OTC DEPARTMENT. PATIENT STATES SHE USED THE HEATING PAD A FEW TIMES SINCE 2025. PATIENT STATES SHE LIVES IN, THEREFORE DOES NOT NEED TO USE HEATING PAD MUCH DUE TO WARM TEMPERATURES. PATIENT STATES SHE NOTICED BURN MARKS ON MATTRESS 3 TO 4 WEEKS AGO. PATIENT STATES SHE DID NOT REPORT IT BECAUSE SHE THOUGHT IT WAS A "FLUKE". PATIENT STATES SHE DECIDED TO REPORT INCIDENT, AFTER RECEIVING LETTER NOTIFYING HER OF AN OVERHEATING DEFECT OF THE PAD EXPLAINED IN THE LETTER FROM. PATIENT REQUESTING REPLACEMENT OF HER MATTRESS. PATIENT DID NOT SUFFER ANY PERMANENT BODILY INJURY. PATIENT STATES SHE STILL HAS THE MATTRESS AND HEATING PAD.
Patient problems: Insufficient Information
MAUDE report 25250529 ↗InjuryMay 21, 2026Temperature Problem
PATIENT USING AN OTC HEATING PAD WRAP FOR SHOULDER AND NECK FROM MANUFACTURER-NAVAJO MANUFACTURING COMPANY INC. ON LOW SETTING AND EXPERIENCED PRODUCT OVERHEATING . PATIENT EXPERIENCED BURNING AND BLISTERING TO NECK AND SHOULDER.
Patient problems: Insufficient Information
MAUDE report 25250525 ↗OtherMay 21, 2026Adverse Event Without Identified Device or Use Problem
BURN AREAS AROUND RIGHT-SIDE SHOULDER AND NECK. ALSO, RIGHT LEG WHERE PRIOR SURGERY AREA WHERE PINS ARE DUE TO COLDNESS; SKIN WATER, OPEN WOUND AND THEN BECAME A SCAR: PILLOW USING BURN MARK AND ALSO THE PAD ITSELF BURNED; STILL HAVE IT. LAST USED BETWEEN 6 WEEKS -2 MONTHS AGO.
Patient problems: Burn(s); Scar Tissue; Unspecified Tissue Injury
MAUDE report 25249709 ↗OtherApr 24, 2026Overheating of Device
PATIENT CALLED TO REPORT RECEIVING LETTER ADVISING OF OVERHEATING ISSUE WITH HEATING PAD (OTC # 448) PURCHASED FROM (B)(6) PHARMACY OTC DEPARTMENT. PATIENT STATES SHE USED THE HEATING PAD A FEW TIMES SINCE (B)(6) 2025. PATIENT STATES SHE LIVES IN (B)(6) THEREFORE DOES NOT NEED TO USE HEATING PAD MUCH DUE TO (B)(6) WARM TEMPERATURES. PATIENT STATES SHE NOTICED BURN MARKS ON MATTRESS 3 TO 4 WEEKS AGO. PATIENT STATES SHE DID NOT REPORT IT BECAUSE SHE THOUGHT IT WAS A "FLUKE." PATIENT STATES SHE DECIDED TO REPORT INCIDENT, AFTER RECEIVING LETTER NOTIFYING HER OF AN OVERHEATING DEFECT OF THE PAD EXPLAINED IN THE LETTER FROM (B)(6). PATIENT REQUESTING REPLACEMENT OF HER MATTRESS. PATIENT DID NOT SUFFER ANY PERMANENT BODILY INJURY. PATIENT STATES SHE STILL HAS THE MATTRESS AND HEATING PAD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24990567 ↗OtherApr 24, 2026Overheating of Device
PATIENT USING AN OTC HEATING PAD WRAP FOR SHOULDER AND NECK FROM MANUFACTURER- NAVAJO MANUFACTURING COMPANY INC. ON LOW SETTING AND EXPERIENCED PRODUCT OVERHEATING. PATIENT EXPERIENCED BURNING AND BLISTERING TO NECK AND SHOULDER.
Patient problems: Blister; Superficial (First Degree) Burn
MAUDE report 24990512 ↗InjuryApr 22, 2026Temperature Problem
PATIENT USING HANDY SOLUTION HEATING PAD WHEN IT CAUGHT FIRE. PATIENT STATES IT WAS ONLY THE 2ND USE ON A NEW HEATING PAD. SHE STATES SHE SMELLED SMOKE/BURNING PLASTIC BEFORE SHE HEARD THE SMOKE DETECTOR OR FELT ANY PAIN DUE TO HER NEUROPATHY. MEMBER REPORTS REDNESS AND PAIN ON THE SKIN IN THE AREA WHERE THE HEATING PAD HAD BEEN.SHE REPORTS NO BLISTERS OR DEEPER BURNS, SHE USED ALOE AND THE AREA HEALED IN A FEW WEEKS. PATIENT HAS NEUROPATHY POTENTIALLY CAUSINGHER NOT TO FEEL THE OVERHEATING OF THE HEATING PAD BEFORE IT CAUGHT FIRE.
Patient problems: Insufficient Information
MAUDE report 24949293 ↗InjuryApr 22, 2026Temperature Problem
MATERIAL HAD A SMALL HOLE. BEFORE USING IT THERE WAS SOME ORANGE THINGS ON THE MATERIAL. SHE STARTED USING IT, SMELLED SMOKE, TOOK IT OFF, LOOKED AT IT AND THEN THERE WAS A HOLE AND WIRES WERE EXPOSED. SHE DID NOT GET BURNED.
Patient problems: Insufficient Information
MAUDE report 24949283 ↗OtherApr 8, 2026Fire; Patient Device Interaction Problem
PATIENT USED NECK AND BACK HEATING PAD FROM NAVAJO MANUFACTURING COMPANY INC. PRODUCT WAS ITEM #448 FROM (B)(6) OTC CATALOG HEATING PAD WRAP FOR SHOULDER AND NECK. PATIENT FELL ASLEEP ON IT AND WOKE UP TO THE SMELL OF FIRE. PATIENT'S PILLOW HAD A HOLE BURNED INTO IT AND PATIENT HAD A BURN ON HER NECK THAT BLISTERED. PATIENT STOPPED USE IMMEDIATELY.
Patient problems: Partial thickness (Second Degree) Burn
MAUDE report 24819529 ↗InjuryApr 8, 2026Temperature Problem
IT ALMOST CAUGHT HER HOUSE ON FIRE AND BURNED HER ROBE.
Patient problems: Insufficient Information
MAUDE report 24814307 ↗InjuryApr 8, 2026Temperature Problem
HEATING PAD OVERHEATED AND CAUSED BURNS ON SHOULDERS. THE PRODUCT MELTED ITS OWN SWITCH AND NEEDED TO BE UNPLUGGED/COULD NOT BE SHUT OFF.
Patient problems: Insufficient Information
MAUDE report 24814215 ↗InjuryApr 8, 2026Temperature Problem
USER STATED THE SWITCH GETS SO HOT AFTER BEING TURNED ON 10 MIN OR SO, THAT IT'S TOO HOT TO TOUCH. HE GOT BURNED BY TRYING TO TURN IT OFF.
Patient problems: Insufficient Information
MAUDE report 24814196 ↗InjuryMar 23, 2026Fire
MEMBER CALLED IN (B)(6) 2026 AND STATED THAT ON (B)(6) SHE TRIED TO USE PRODUCT AT NIGHT ON HER BACK AND IT CAUGHT FIRE ON HER MATTRESS.
Patient problems: Insufficient Information
MAUDE report 24667907 ↗InjuryMar 23, 2026Fire
PRODUCT CAUGHT FIRE AND BURNED ARM.
Patient problems: Superficial (First Degree) Burn
MAUDE report 24667905 ↗InjuryMar 4, 2026Overheating of Device
USER STATES THE SECOND TIME SHE USED IT, SOMETHING SMELLED HOT. DID NOT STATE IT CAUGHT ON FIRE, BUT SHE DID STATE HER BACK WAS BURNED AND BLISTERED. WENT TO THE ER, GOING TO BURN AND WOUND PLASTIC SURGERY CENTER ON.
Patient problems: Insufficient Information
MAUDE report 24511488 ↗InjuryMar 4, 2026Overheating of Device
PRODUCT CAUGHT FIRE AND BURNED ARM.
Patient problems: Insufficient Information
MAUDE report 24511283 ↗InjuryMar 4, 2026Overheating of Device
HEATING PAD CAUGHT FIRE OVERHEATED. MELTED PLASTIC BINDINGS AND SWITCH,HAD TO BE UNPLUGGED TO TURN OFF.
Patient problems: Insufficient Information
MAUDE report 24511209 ↗InjuryMar 4, 2026Overheating of Device
MEMBER CALLED IN (B)(6)2026 AND STATED THAT ON (B)(6) SHE TRIED TO USE PRODUCT AT NIGHT ON HER BACK AND IT CAUGHT FIRE ON HER MATTRESS.
Patient problems: Insufficient Information
MAUDE report 24505001 ↗InjuryMar 4, 2026Overheating of Device
InjuryFeb 5, 2026Excessive Heating
CONSUMER WAS USING HEATING PAD AND IT BURNED THE BACK OF HIS NECK. TESTING WAS DONE ON OTHER UNITS AND DETERMINED THAT WHEN THE PAD IS LAID ON OR BENT IN WAYS THAT ARE RECOMMENDED AGAINST IN THE INSTRUCTIONS FOR THE DEVICE THAT OVERHEATING CAN OCCUR AND CAUSE DAMAGE/BURNING OF THE DEVICE.
Patient problems: Burn(s)
MAUDE report 24272517 ↗InjuryFeb 5, 2026Excessive Heating
CONSUMER WAS USING HEATING PAD AND IT BURNED THE BACK OF HIS NECK. TESTING WAS DONE ON OTHER UNITS AND DETERMINED THAT WHEN THE PAD IS LAID ON OR BENT IN WAYS THAT ARE RECOMMENDED AGAINST IN THE INSTRUCTIONS FOR THE DEVICE THAT OVERHEATING CAN OCCUR AND CAUSE DAMAGE/BURNING OF THE DEVICE.
Patient problems: Burn(s)
MAUDE report 24272507 ↗InjuryFeb 4, 2026Excessive Heating
CONSUMER WAS USING HANDY SOLUTIONS NECK AND SHOULDER HEATING PAD WHILE LAYING IN BED. SHE NOTICED A BURNING SMELL AND FOUND THAT THE HEATING PAD HAD BURNT THROUGH AND BURNED THE BACK OF HER NECK. SHE DID NOT SEEK MEDICAL ATTENTION FOR THE BURN AS IT WAS MINOR. TESTING WAS DONE ON OTHER UNITS AND DETERMINED THAT WHEN THE PAD IS LAID ON OR BENT IN WAYS THAT ARE RECOMMENDED AGAINST IN THE INSTRUCTIONS FOR THE DEVICE THAT OVERHEATING CAN OCCUR AND CAUSE DAMAGE/BURNING OF THE DEVICE.
Patient problems: Burn(s)
MAUDE report 24261000 ↗
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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 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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