Homedics SP-6HJA-2Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00031262107145), received between Feb 2, 2023 and Apr 13, 2023 — classified as 4 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 13, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  WE RECEIVED THE FEEDBACK FROM IMPORTER ON (B)(6) 2023 ABOUT THE EVENT SAID THAT ONE CONSUMER ALLEGED THAT THE MASSAGER OVERHEATED AND BURNED THE SKIN OFF HER BACK AND SCALP AND BURNED OUT HER HAIR.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 16740002 ↗
• InjuryMar 31, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  WE RECEIVED THE FEEDBACK FROM IMPORTER ON 03-FEB-2023 ABOUT THE EVENT SAID THAT ONE CONSUMER ALLEGED THEY GOT 2ND DEGREE BURNS WITH SKIN PEELED OFF HER BACK. THE END USER ALLEGED THEY PURCHASED OUR PRODUCT ON THE 12-DEC-2022 AND WOKE UP ON (B)(6) 2022 WITH THE BURNS.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 16655810 ↗
• InjuryFeb 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE END USER CLAIMED THE FOLLOWING: "I WANTED TO REPORT HOW DISSATISFIED WITH YOUR HOMEDICS NECK AND BACK HEATED MASSAGER FROM WALMART. THE MASSAGER OVERHEATED AND BURNED THE SKIN OFF MY BACK AND SCALP AND BURNED OUT MY HAIR. I HAVE PLENTY OF PICTURES AND PROOF OF INJURY AND HOW YOUR PRODUCT CAUSED IT. I HAVE RETAINED A LAWYER AND WILL BE FILING A LAWSUIT FOR MY PAIN AND SUFFERED. PRODUCT DEFECT. PERSONAL INJURY WITH 98% CHANCE OF WINNING. I'M VERY DISAPPOINTED BUT NOT ANGRY. JUST EMOTIONAL. I HAD BEEN GROWING MY HAIR FOR YEARS..."

  Patient problems: Burn(s); Hair Loss

  MAUDE report 16410248 ↗
• InjuryFeb 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CONSUMER ALLEGATION: "SAID SHE GOT 2ND DEGREE BURNS. SAID SKIN PEELED OFF HER BACK. IT BURNED THROUGH HER CLOTHES. HAD BLACK BURNS. CALLING TO INFORM AND MAKE US AWARE. SAID PURCHASED ON THE 12TH AND WOKE UP ON 13TH WITH BURNS. OFFERED LABEL TO RETURN IT FOR TESTING. CONSUMER SAID SHE ISNT SURE... SAID MAYBE SHE SHOULD CONTACT AN ATTORNEY. SAID THIS ISEXTREMELY UPSETTING. HAS CAUSED A LOT OF PAIN. A LOT OF SUFFERING."

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 16288102 ↗