Homedics FMS-347HJRecalls & reported problems
Health Care Massage Branch of Zhangzhou Easepal Industrial Co., Ltd. · Shiatsu + air 4.0 foot massager with heat · Class 1
Data updated Oct 18, 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 00031262113702), received between Mar 16, 2026 and Mar 16, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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.
Reports received per month
Most reported problems
Device problems
- Improper or Incorrect Procedure or Method1
- Use of Device Problem1
Patient problems
- Bacteremia1
- Partial thickness (Second Degree) Burn1
- Unspecified Infection1
- Unspecified Tissue Injury1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 16, 2026Use of Device Problem; Improper or Incorrect Procedure or Method
A NEW USER OF THE HEATED FOOT MASSAGER RECEIVED BURNS TO HER FEET WHICH LED TO AN INFECTION AND ULTIMATELY A TOE AMPUTATION. THE USER WAS GIVEN THE FOOT MASSAGER TO USE AND IGNORED ALL WARNINGS THAT WOULD HAVE PROHIBITED HER FROM ITS USE. THE USE SUFFERS FROM DIABETES AND DIABETIC NEUROPATHY IN HER HANDS, LEGS, AND FEET. THE IFU VERY CLEARLY STATES THAT THIS PRODUCT IS NOT FOR DIABETICS, SENSORY DEFICIENCIES, AND OTHER CONDITIONS AS WELL THAT SHE POSSESSED. THE APPLICABLE WARNINGS/CAUTIONS, THAT WERE IGNORED, ARE AS FOLLOWS: ·NOT FOR USE BY DIABETICS -·CONSULT YOU DOCTOR PRIOR TO USING THIS PRODUCT, IF: YOU HAVE ANY CONCERNS REGARDING YOUR HEALTH. ·IF AT ANY TIME, SORENESS, RASH, OR PAIN OCCURS, DISCONTINUE USE AND CONSULT YOUR PHYSICIAN. ·DO NOT USE MORE THAN 15 MINS AT A TIME. ·NEVER USE THIS PRODUCT DIRECTLY ON SWOLLEN OR INFLAMED AREAS. ·THIS PRODUCT SHOULD NEVER BE USED BY AN INDIVIDUAL SUFFERING FROM ANY PHYSICAL AILMENT THAT WOULD LIMIT THE USER'S CAPACITY TO OPERATE THE CONTROLS, OR WHO HAS SENSORY DEFICIENCIES. DUE TO THE USERS' MEDICAL CONDITIONS, HER SKIN WAS IN A FRAGILE STATE. SHE WAS ALSO UNABLE TO FEEL THAT TEMPERATURE WAS TOO HOT FOR HER FRAGILE TISSUE AND WAS UNABL
Patient problems: Bacteremia; Partial thickness (Second Degree) Burn; Unspecified Infection; Unspecified Tissue Injury
MAUDE report 24608197 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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