HOMEDICS FB-380HJ-1PKRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00031262082268), received between Sep 15, 2022 and Nov 30, 2022 — classified as 2 deaths, 1 malfunction.

The most frequently reported specific device problem is “Excessive Heating” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 30, 2022Smoking; Smoking

  CONSUMER REPORTED HE SOMETIMES WILL DOZE OFF WHILE USING THE SPA BECAUSE IT'S SO RELAXING. ON THIS NIGHT, HE WAS CLOSE TO DOZING OFF, BUT NOTICED A FUNNY SMELL, FOLLOWED BY SMOKE. HE SAW THE SMOKEY BUBBLES COMING OUT OF THE WATER AND NOTICED THE WATER WAS BURNING HIS FEET. HE PULLED HIS FEET OUT, SMOKE WAS FILLING THE ROOM. HE UNPLUGGED THE DEVICE AND RAN IT OUTSIDE. WHEN THE SMOKE CLEARED, HE FOUND A BURN IN HIS FLOOR. HE LOOKED AT THE FOOT SPA AND IT WAS CLEARLY BURNED. PHOTOGRAPHS OF THE FOOTBATH WERE PROVIDED.

  Patient problems: Burn(s)

  MAUDE report 15891332 ↗
• DeathNov 17, 2022Off-Label Use; Therapeutic or Diagnostic Output Failure; Excessive Heating; Off-Label Use; Therapeutic or Diagnostic Output Failure; Excessive Heating

  ON OR ABOUT (B)(6) 2021, THE PATIENT'S PERSONAL CARE ATTENDANT PREPARED A BUBBLE BLISS ELITE FOOTBATH BATHING MACHINE THAT SHE HAD PURCHASED. SHE FILLED THE BASIN WITH WATER, TURNED ON THE MACHINE, AND PLACED THE PATIENT'S FEET IN THE BASIN TO SOAK. THE BUBBLE BLISS ELITE FOOTBATH IS DESIGNED TO PROVIDE A "HEAT BOOST" THAT HEATS THE WATER TO A THERAPEUTIC TEMPERATURE. UNFORTUNATELY, HOWEVER, WHILE THE PATIENT'S FEET REMAINED SOAKING IN THE BASIN, THE MACHINE ALLEGEDLY HEATED THE BASIN WATER RAPIDLY AND IMPROPERLY TO A HOT TEMPERATURE CAUSING BURNS TO THE PATIENT'S FEET. THE PATIENT SUFFERS FROM DIABETIC NEUROPATHY AND WAS UNABLE TO DISCERN THE RISING WATER TEMPERATURE WHILE SOAKING IN THE FOOTBATH MACHINE. SUMMARY PER THE EMS RECORD: AMBULANCE "DISPATCHED TO LOCATION TO A 59 Y/O MALE CHIEF COMPLAINT OF BURNS TO HIS FEET. UPON ARRIVAL, EMS IS MET DOWNSTAIRS AND ESCORTED TO UPSTAIRS APARTMENT. PT IS LAYING SEMI-FOWLER'S IN BED IN BACK ROOM, AWAKE AND ALERT. HOME HEALTH CARE NURSE STATES SHE GOT A NEW FOOT BATH AND WAS GETTING READY TO CLEAN PT'S FEET, BUT DID NOT REALIZE THE WATER TEMPERATURE BEFORE SUBMERGING PT'S FEET INTO BATH. UPON EMS ARRIVAL, PT HAS PARTIAL THICKNESS BURNS TO B

  Patient problems: Device Overstimulation of Tissue; Partial thickness (Second Degree) Burn; Post Operative Wound Infection

  MAUDE report 15812544 ↗
• DeathSep 15, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  ON AUGUST 17, 2022 HOMEDICS WAS SEVERED WITH A LAWSUIT THAT ALLEGED THE FOLLOWING: ON OR ABOUT (B)(6) 2021, MS. (B)(6) (PERSONAL CARE ATTENDANT) ARRIVED AT MR. (B)(6) HOME IN (B)(6), TO PROVIDE BATHING AND OTHER CUSTODIAL SERVICES. MS. (B)(6) BROUGHT A BUBBLE BLISS ELITE FOOTBATH BATHING MACHINE, FILLED THE BASIN WITH WATER, TURNED ON THE MACHINE, AND PLACED MR. (B)(6) FEET IN THE BASIN TO SOAK. THE BUBBLE BLISS ELITE FOOTBATH IS SUPPOSED TO PROVIDE A "HEAT BOOST" TO HEAT THE WATER TO A THERAPEUTIC TEMPERATURE. UNFORTUNATELY, HOWEVER, WHILE MR. (B)(6) FEET REMAINED SOAKING IN THE BASIN, THE MACHINE RAPIDLY AND IMPROPERLY HEATED THE BASIN WATER TO A HOT TEMPERATURE CAUSING MR. (B)(6) FEET TO BURN. MR. (B)(6) SUFFERS FROM DIABETIC NEUROPATHY, AND HE WAS UNABLE TO DISCERN THE RISING WATER TEMPERATURE WHILE SOAKING IN THE MACHINE. LATER THAT EVENING, MR. (B)(6) BEGAN TO EXPERIENCE SIGNIFICANT PROBLEMS SECONDARY TO BURNS TO BOTH FEET. MR. (B)(6) WAS TAKEN BY AMBULANCE TO (B)(6) MEDICAL CENTER FOR EMERGENT MEDICAL CARE. AFTER A PROLONGED COURSE OF MEDICAL CARE AND ATTENTION, MR. (B)(6) BURNS DID NOT IMPROVE, AND HIS DOCTORS CONCLUDED THAT THE ONLY TREATMENT OPTION WAS A DOUBLE AMPUTATION

  Patient problems: Burn(s)

  MAUDE report 15429348 ↗