JOULERecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00863249000305), received between May 24, 2017 and May 22, 2026 — classified as 15 injuries.

The most frequently reported specific device problem is “Use of Incorrect Control/Treatment Settings” (6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryMay 22, 2026Use of Incorrect Control/Treatment Settings

  BBL HEROIC DEMO TO CHEST RESULTED IN SMALL BURNS.

  Patient problems: Blister; Partial thickness (Second Degree) Burn; Skin Infection

  MAUDE report 25263002 ↗
• InjuryApr 23, 2026Use of Incorrect Control/Treatment Settings

  PATIENT CALLED SCTION SERVICE ON (B)(6) 2026 REPORTING AN ADVERSE EVENT FROM THE TREATMENT ON (B)(6) 2024.

  Patient problems: Blister

  MAUDE report 24974419 ↗
• InjuryFeb 3, 2026Use of Incorrect Control/Treatment Settings

  ON (B)(6) 2025: SCITON CLINICAL RECEIVED AN EMAIL FROM CLINIC PHYSICIAN REPORTING THAT AN ADVERSE OUTCOME HAD OCCURRED WHILE PERFORMING A BBL ON A PATIENT WHO CAME IN FOR A ROSACEA TREATMENT. CLINIC PHYSICIAN STATED THAT THE SCITON SALES REPRESENTATIVE ADVISED HER TO EMAIL SCITON CLINICAL DEPARTMENT TO PROVIDE FURTHER GUIDANCE.

  Patient problems: Blister; Swelling/ Edema

  MAUDE report 24254542 ↗
• InjuryFeb 3, 2026Adverse Event Without Identified Device or Use Problem

  IDENTICAL FDA MEDWATCH FORMS MW5180771 AND MW5180772 WERE RECEIVED WITH THE FOLLOWING DESCRIPTION OF EVENT: " BBL AND HALO TREATMENT. I WENT IN TO GET A MEDICAL/COSMETIC PROCEDURE, AND THE DOCTOR USED EQUIPMENT AND I WAS BURNED. I REPEATEDLY REACHED OUT TO CLINIC OVER THE COURSE OF THE WEEK AFTER FROM (B)(6) 2025. I WAS TOLD EACH TIME THAT THIS WAS NORMAL, AND I WAS HEALING IN THE RIGHT DIRECTION. I HAD EXTREME SWELLING ON MY FACE WHERE I COULD NOT OPEN MY EYES, I WAS SO SWOLLEN I WAS UNRECOGNIZABLE, COVERED IN BLISTERS. I REACHED OUT A FINAL TIME, AND THE DOCTOR WAS THEN STATING THAT IT WAS NOT NORMAL, SHE STATED SHE HAD NOT SEEN MY PICTURES I WAS SENDING THROUGH PORTAL KIARA SINCE (B)(6) 2025 WHICH CONTRADICTED PREVIOUS VOICEMAILS SHE HAD LEFT ON MY PHONE. THE DOCTOR'S RETURNED CALL WAS ACCUSATORY NATURE, WHEREAS SHE BLAMED ME FOR POTENTIALLY NOT DISCLOSING ANY UNDERLYING CONDITIONS, IN WHICH I DEFENDED MYSELF AS I HAD NONE. THEN SHE PRESCRIBED STEROIDS AND AN ANTIBIOTIC, ONCE I COULD OPEN MY EYES, I DROVE MYSELF TO THE HOSPITAL EMERGENCY, THEN DID A FULL BLOOD PANEL AND I WAS EXAMINED, THEY NOTED MY BLISTERS AND BURNS AND DISCHARGED ME, STATING THERE WAS NO UNDERLYING CONDITIONS

  Patient problems: Swelling/ Edema

  MAUDE report 24254538 ↗
• InjuryOct 22, 2025Use of Incorrect Control/Treatment Settings; Use of Incorrect Control/Treatment Settings

  10/1/25: SCITON CLINICAL EDUCATION DEPARTMENT RECEIVED AN EMAIL FROM CLINIC PA-C REGARDING PATIENT THAT HAD EXPERIENCED BURNS WITH BBL. THE PATIENT WAS COMING INTO THE OFFICE FOR A BBL PIGMENTATION TREATMENT ON ARM ON (B)(6) 2025. CLINIC PA-C INCLUDED SETTINGS AND PHOTOS WITHIN THE EMAIL AND STATED THAT THE PATIENT DENIED RECENT SUN EXPOSURE, ANTIBIOTICS, OR TOPICALS. TREATMENT SETTINGS WERE AS FOLLOWS: SKIN TYPE IV, 515NM, SQUARE ADAPTER, 7>8>9>10 J, 20MS, 18 C (2 PASSES).

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 23361460 ↗
• InjurySep 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER CONTACTED SCITON SERVICE WITH AN ID 714 ERROR ON BBL HANDPIECE. CUSTOMER REPORTED THAT THE POWER WENT OUT IN THE BUILDING AND THAT THE PATIENT HAD AN ADVERSE CLINICAL REACTION TO THE TREATMENT.

  Patient problems: Blister

  MAUDE report 20317326 ↗
• InjuryNov 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  10/26/2023: SCITON RECEIVED THE FOLLOWING EMAIL FROM THE PATIENT. I WOULD LIKE TO SPEAK WITH CUSTOMER SERVICE IN REFERENCE TO A COMPLICATION THAT OCCURRED WHILE BEING TREATED WITH THE SCITON LASER PRODUCT BY MY FORMAL DERMATOLOGIST DR. (B)(6). DUE TO COMPLICATIONS I WAS TREATED WITH TWO ORAL ANTIBIOTICS, ONE TOPICAL CREAM ANTIBIOTIC, PRESCRIPTION METHYPREDNISOLONE AND DR.'S OFFICE SKIN CARE PRODUCTS ZO SKIN HEALTH. FOUR WOUND SWAB CULTURES WERE COMPLETED WITH THE RESULT FROM A BURN ON MY FACE RESULTING WITH THE BACTERIAL INFECTION PSEUDOMONAS. THIS PROCEDURE WAS RECOMMENDED TO ME ON MY YEARLY SKIN CHECK EXAM (HISTORY OF SKIN CANCER OF FACE). I AM REQUESTING ADDITIONAL INFORMATION ABOUT THE PRODUCT MACHINE AS THE MD SAID THAT THE SETTINGS WERE STANDARD FOR WHAT HE PLANNED. AS A NURSE, I QUESTIONED DR. PRIOR TO AGREEING TO SUCH A PROCEDURE AND WAS REASSURED THEIR WOULD BE ONLY MILD SWELLING, REDNESS, MILD DISCOMFORT AND MENDS AFTER BE EVALUATED BY 48 HOURS. I WOULD APPRECIATE HEARING BACK FROM YOUR COMPANY AS THE RECOVERY TOOK SEVERAL MONTHS WITH SCARRING. THE PROCEDURE WAS DONE IN (B)(6) 2022 AND I FINALLY HAVE MADE AN APPOINTMENT TO FOLLOW UP WITH ANOTHER DERMATOLOGIST ONE YEAR POS

  Patient problems: Bacterial Infection

  MAUDE report 18211862 ↗
• InjuryNov 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ADVERSE EVENT REPORTED FOR A PATIENT WHO HAD FACE AND NECK LIFT PROCEDURE WITH HALO APPLICATION WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 18116773 ↗
• InjuryOct 5, 2023Use of Incorrect Control/Treatment Settings; Use of Incorrect Control/Treatment Settings

  ON 09/15/2023, SCITON RN RECEIVED AN EMAIL FROM CLINIC REPORTING THAT THE PATIENT EXPERIENCED BBL BURNS ON HER FACE FROM THE PROCEDURE WITH BBL ON (B)(6) 2023.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 17882144 ↗
• InjuryJul 25, 2023Use of Incorrect Control/Treatment Settings; Use of Incorrect Control/Treatment Settings

  ON (B)(6) 2023, IT WAS REPORTED THAT A PATIENT TREATED WITH CLEAR V FOR PORT WINE STAIN EXPERIENCED AN ADVERSE EVENT.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 17390502 ↗
• InjuryAug 9, 2019Break

  THE PT HAD A BBL TREATMENT WITH THE SCITON JOULE, APPROPRIATE SETTING AND SHE HAD FIRST AND SECOND DEGREE BURNS TO HER CHEST AND NECK. A TEST SPOT WAS DONE. THE RECOMMENDATIONS IN THE MANUAL WERE FOLLOWED BUT WERE NOT CLEAR ABOUT WHERE TO PUT THE GEL ON THE DEVICE. THE DEVICE WAS THEN CHECKED BY THE MFR'S SERVICE STAFF AND FOUND TO BE OKAY AND SAID USE A LARGE AMOUNT OF GEL ON THE SAPPHIRE TIP AND THE SNAP ON ADAPTER. THIS DIFFERS FROM THE MANUAL RECOMMENDATIONS AND THE CONTAINER FOR THE SNAP ON ADAPTER. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Partial thickness (Second Degree) Burn; Superficial (First Degree) Burn

  MAUDE report 8883560 ↗
• InjuryNov 14, 2018Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018 I UNDERWENT 3RD TREATMENT FOR LASER VAGINAL THERAPY. THE FIRST TWO TREATMENTS WERE UNREMARKABLE. SEVERAL DAYS FOLLOWING THE 3RD TREATMENT, I EXPERIENCED SOME DISCHARGE, ITCHING AND DYSURIA. ON (B)(6) WENT ON A 7 DAY COURSE OF AMOX-CLOV 500MG-125 MG WITH NO RESOLUTION. VISITED FAMILY MEDICINE ON (B)(6) WITH CONTINUED COMPLAINT OF DYSURIA. WET PREP REVEALED BACTERIA AND WENT ON A 7 DAY COURSE OF FLAGYL. DYSURIA CONTINUED. (B)(6), SAID UROLOGIST, DIAGNOSED WITH UTI, AND NOW ON 7 DAY COURSE OF CEFTIN. CONCOMITANT MEDICAL: SYNTHROID, METFORMIN, LISINOPRIL, LIPITOR, NEXIUM, YUVAFEM, BABY ASPIRIN, DAILY VITAMIN.

  Patient problems: Discharge; Dysuria; Itching Sensation; Urinary Tract Infection

  MAUDE report 8071626 ↗
• InjuryApr 17, 2018Adverse Event Without Identified Device or Use Problem

  PATIENT HAD BBL AND HALO PROCEDURES IN (B)(6) 2016 AT (B)(6). THE PATIENT REPORTED THAT THE RESULTS WERE DISASTROUS; INSTEAD OF IMPROVING THE PATIENT'S SKIN, IT BURNED THE SKIN IN SEVERAL AREAS, DESPITE USING SETTINGS RECOMMENDED FOR ETHNIC DARK SKIN FOR ASIAN INDIAN SKIN. PATIENT ALSO REPORTED THAT AFTER ONE YEAR, SHE STILL HAS PROMINENT DARK SPOTS WHICH SHE IS UNABLE TO CONCEAL WITH MAKE-UP, AND ALSO REPORTED THAT THERE ARE MARKS LEFT BY THE SPOTS THAT FADED.

  Patient problems: Burn, Thermal

  MAUDE report 7438534 ↗
• InjuryDec 28, 2017Insufficient Device Problem Information

  ON (B)(6) 2017, THE DATE OF (B)(6) INJURY, SHE WENT TO (B)(6) DERMATOLOGY FOR TREATMENT FOR HYPERTRICHOSIS. SHE WAS TREATED BY (B)(6) D.O. (B)(6) WAS THERE FOR TREATMENT TO HER LEGS AND ONCE THE TREATMENT BEGAN, HER LEG TURNED VERY RED AND DR. (B)(6) STOPPED TREATMENT AND GAVE HER CLODERM. THE RECORDS FURTHER INDICATE THAT SHE WAS SUNBURNED PRIOR TO RECEIVING TREATMENT AND WAS PRESCRIBED LUXAMEND TOPICAL CREAM TO TREAT HER SUNBURN. THE TREATMENT PARAMETERS DURING THIS PROCEDURE WERE IPL 590NM FILTER MODULE WITH 15 X 45 MM SPOT SIZES. FLUENCE: 12 J/CM2. TOTAL PASSES: 1 AND COOLING WAS PERFORMED AT 10 DEGREES CELSIUS. AT THE TIME OF THE TREATMENT, (B)(6) REPORTED MEDICATIONS WERE TRIAMCINOLONE TOPICAL CREAM, LATISSE FOR EYELASHES, VENLAFAXINE, MYCOPHENOLATE, PLAQUENIL, SILDENAFIL, AND RITUXIMAB. (B)(6) RETURNED TO (B)(6) FOR A FOLLOW-UP APPOINTMENT THE NEXT DAY, (B)(6) 2017, WITH A PURPORTED FIRST DEGREE BURN AND ALLEGED THE BURN WAS CAUSED BY TREATMENT THE DAY BEFORE. SHE REPORTED HAVING PAINFUL, ITCHY LEGS, MODERATE IN SEVERITY. DR. (B)(6) ADVISED HER TO USE WET COMPRESSES, ALOE MOISTURIZERS, AND NON-STEROIDAL ANTI-INFLAMMATORY DRUGS. DR. (B)(6) ALSO PRESCRIBED SILVADENE 1% TOPICAL

  Patient problems: Burning Sensation; Erythema; Itching Sensation; Pain; Superficial (First Degree) Burn; Tissue Damage

  MAUDE report 7152006 ↗
• InjuryMay 24, 2017Device Operates Differently Than Expected

  ON (B)(6) 2017 A LASER TECH AT MEDICAL AESTHETICS AND LASER PERFORMED A BBL TREATMENT FOR HAIR REDUCTION ON A FITZPATRICK SKIN TYPE VI PATIENT RESULTING IN STRIPING, CRUST, PEEL AND A 2ND DEGREE BURN OF HER LOWER FACE.

  Patient problems: Partial thickness (Second Degree) Burn; Peeling; Skin Tears

  MAUDE report 6589463 ↗