RHA® 3 Mepi RHA® 3 Mepi - TSK - USRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07640173236177), received between Feb 9, 2026 and Jul 14, 2026 — classified as 5 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJul 14, 2026Adverse Event Without Identified Device or Use Problem

  DELAYED INFLAMMATION EVENT "[DERMAL FILLER REACTION]" ("[SKIN INDURATION]", "[SKIN OEDEMA]"). CASE NARRATIVE: ON 23-JUN-2026, PRIMEVIGILANCE NOTIFIED TEOXANE GENEVA OF AN ADVERSE EVENT FROM THE UNITED STATES. ACCORDING TO THE INFORMATION RECEIVED FROM THE INJECTOR, A PATIENT WAS INJECTED ON (B)(6) 2026 WITH RHA 3 IN THE LIPS WITH A NEEDLE. THE PATIENT HAD A HISTORY OF COLD SORES. IN (B)(6) 2026 (UNSPECIFIED DATE, REPORTED AS "RECENTLY"), THE PATIENT EXPERIENCED A COLD SORE OUTBREAK AND WAS STARTED ON VALTREX. THE SYMPTOMS ALMOST COMPLETELY RESOLVED. ON (B)(6) 2026, THE PATIENT STARTED TO COMPLAIN ABOUT SWELLING IN HER LIPS. THE INJECTOR CONFIRMED THAT THE AREAS OF FILLER WERE FIRM/HARDENED (PHOTOS PROVIDED) AND BELIEVED THAT THE COLD SORE OUTBREAK TRIGGERED A DELAYED INFLAMMATION EVENT. ON (B)(6) 2026, THE SWELLING WORSENED (PHOTOS PROVIDED). THE PATIENT WAS ON MEDROL AND RECEIVED HYALURONIDASE (3 VIALS). DUE TO THE SEVERITY OF THE EVENT OF SWELLING, THE CASE WAS ASSESSED AS REPORTABLE. THE OUTCOME OF THE EVENT WAS UNKNOWN. AT THE TIME OF THIS REPORT, NO ADDITIONAL INFORMATION WAS OBTAINED REGARDING THE OUTCOME OF THE EVENT. THE EVOLUTION OF THE SYMPTOMS IS BEING MONITORED.

  Patient problems: Implant site sclerosis; Inflammation; Swelling/ Edema

  MAUDE report 25812730 ↗
• InjuryJun 1, 2026Improper or Incorrect Procedure or Method

  SUSPICION OF VASCULAR OCCLUSION/5-6 SECOND CAPILLARY REFILL [VASCULAR SKIN DISORDER] ([PALLOR]). CLIENT TOLERATED INJECTIONS WELL/MINIMAL BLEEDING NOTED [INJECTION SITE HAEMORRHAGE]. MINIMAL BRUISING - HYALAZE INJECTED INTO UPPER LIP [INJECTION SITE HAEMORRHAGE]. CASE NARRATIVE: ON 05-MAY-2026, PRIMEVIGILANCE NOTIFIED TEOXANE GENEVA OF AN ADVERSE EVENT FROM THE UNITED STATES. ACCORDING TO THE INFORMATION RECEIVED FROM THE INJECTOR, A PATIENT WAS INJECTED ON (B)(6) 2026 WITH 0.6 ML OF RHA 3 IN THE UPPER AND BOTTOM LIPS WITH THE "RUSSIAN" INJECTION TECHNIQUE. THE PATIENT DID NOT HAVE ANY SIGNIFICANT MEDICAL HISTORY OR KNOWN DRUG ALLERGIES. SEVERAL YEARS AGO SHE HAD A WISDOM TEETH REMOVAL. PATIENT'S CONCOMITANT MEDICATION INCLUDED ZEPBOUND, FLUOXETINE AND BUSPIRONE. ON (B)(6) 2026, AFTER THE INJECTION, THE PATIENT EXPERIENCED MINIMAL BLEEDING. SHE HAD ARNICA GEL APPLIED AND TOLERATED WELL THE INJECTIONS. ON (B)(6) 2026,IN THE MORNING, THE PATIENT EXPERIENCED A SMALL WHITE AREA AND CAM BACK TO THE INJECTOR (NURSE) FACILITY FOR A SUSPICION OF VASCULAR OCCLUSION. THE LATER NOTED A SMALL AREA ON THE LEFT UPPER LIP THAT WAS WHITE WITH 5-6 SECOND CAPILLARY REFILL. PATIENT DENIED PAIN AND IN

  Patient problems: Foreign Body Embolism; Local Reaction; Skin Discoloration

  MAUDE report 25348462 ↗
• InjuryMay 28, 2026Off-Label Use; Improper or Incorrect Procedure or Method

  VASCULAR OCCLUSION [VASCULAR SKIN DISORDER] HISTAMINE RESPONSE AFTER TREATMENT [TYPE I HYPERSENSITIVITY] ([SKIN OEDEMA]) RHA3 IN CHIN [OFF LABEL USE] . CASE NARRATIVE: ON 28-APR-2026, PRIMEVIGILANCE NOTIFIED TEOXANE GENEVA OF AN ADVERSE EVENT FROM THE UNITED STATES. ACCORDING TO THE INFORMATION RECEIVED FROM A HEALTH CARE PROFESSIONAL, A PATIENT WAS INJECTED ON (B)(6) 2026 WITH RHA 3 MEPI IN THE CHIN, NASOLABIAL FOLDS, AND LIPS (NO FURTHER INFORMATION). ON (B)(6) 2026, IMMEDIATELY AFTER TREATMENT, THE PATIENT EXPERIENCED A HISTAMINE RESPONSE WITH SWELLING OF THE INJECTED AREAS BUT ALSO A SWELLING OF THE EYES AND THE NECK. THESE EVENTS WERE RESOLVED WITHOUT TREATMENT. THE PATIENT HAD ALSO EXPERIENCED A VASCULAR OCCLUSION; THE FILLER WAS DISSOLVED AND THE SYMPTOMS RESOLVED. DUE TO THE SERIOUSNESS OF THE EVENT, THE CASE WAS ASSESSED AS REPORTABLE. CONSIDERING THE RESOLUTION OF THE SYMPTOMS, THE COMPLAINT WAS CONSIDERED CLOSED. IMDRF CODE ANNEX G IS ERRONEOUS IS THIS CASE (DUE TO DATABASE ISSUE). PLEASE CONSIDER CODE G04127 ¿ SYRINGE (FDA 987).

  Patient problems: Foreign Body Embolism; Hypersensitivity/Allergic reaction; Swelling/ Edema

  MAUDE report 25313827 ↗
• InjuryApr 21, 2026Adverse Event Without Identified Device or Use Problem

  VASOVAGAL EVENTS/VASOVAGAL SYNCOPE/LOST CONSCIOUSNESS FOR A FEW SECONDS [SYNCOPE] ([HYPOTENSION]) RHA 3 IN THE MIDFACE [OFF LABEL USE]. CASE NARRATIVE: ON 23-MAR-2026, PRIMEVIGILANCE NOTIFIED TEOXANE GENEVA OF AN ADVERSE EVENT FROM THE UNITED STATES. ACCORDING TO THE INFORMATION RECEIVED FROM THE INJECTOR, A MALE PATIENT WAS INJECTED ON (B)(6) 2026 WITH 1 ML RHA 3 IN THE MIDFACE WITH A CANNULA. THE PATIENT'S HISTORY INCLUDED BOTULINUM TOXIN (BOTOX) IN AN UNKNOWN DATE IN FRONTALIS, GLABELLA, AND CROW'S FEET AND HYPERTENSION WITH NO ADVERSE EVENT REPORTED. THE PATIENT'S CONCOMITANT MEDICATION INCLUDED AMLODIPINE AND TELMISARTAN/HYDROCHLOROTHIAZIDE FOR HYPERTENSION. ON (B)(6) 2026, ON THE SAME DAY, THE PATIENT EXPERIENCED TWO VASOVAGAL SYNCOPE EPISODES WHICH OCCURED AFTER COMPLETION OF THE TREATMENT AND DURING WHICH THE PATIENT LOST CONSCIOUSNESS FOR A FEW SECONDS. BETWEEN THE TWO EPISODES THE PATIENT RETURNED TO BASELINE. ONCE CONSCIOUSNESS WAS RESTORED THE PATIENT WAS PLACED IN TRENDELENBURG POSITION, AND RECEIVED COLD PACKS, ORAL FLUIDS AND A GRANOLA BAR. THE BLOOD PRESSURE WAS MEASURED AFTER THE SECOND EPISODE AT 87/47 MMHG AND RETURNED TO BASELINE ALLOWING THE PATIENT TO LEAVE TH

  Patient problems: Low Blood Pressure/ Hypotension; Syncope/Fainting

  MAUDE report 24937663 ↗
• InjuryFeb 9, 2026Off-Label Use

  ON 12/31/2025, PRIMEVIGILANCE NOTIFIED TEOXANE GENEVA OF AN ADVERSE EVENT. THE CASE WAS REPORTED BY AN AMERICAN INJECTOR. ACCORDING TO THE INFORMATION RECEIVED, A FEMALE PATIENT WAS INJECTED ON (B)(6) 2025 WITH 0.6 ML OF RHA 3 MEPI IN THE LEFT TEMPLE. THE INJECTION WAS DONE WITH A CANNULA 25G, USING THE FANNING INJECTION TECHNIQUE (USING A LATERAL CHEEK PORT SITE INTO THE LEFT TEMPLE SPACE). THE SAME DAY, THE PATIENT RECEIVED DYSPORT IN THE GLABELLA, IN THE FOREHEAD, IN THE CROWS FEET AND IN THE NECK. NO COMPLICATIONS WERE NOTED AT THE TIME OF THE INJECTION. ON (B)(6) 2025, THE PATIENT INFORMED HER INJECTOR OF AN ADVERSE EVENT. ACCORDING TO THE INJECTOR, ON (B)(6) 2025, THE PATIENT EXPERIENCED A BURNING SENSATION, SCALING AND REDNESS FROM THE LEFT EYE EXTENDING TO THE HAIRLINE. THE PATIENT INFORMED THE INJECTOR THAT THE SYMPTOMS SPONTANEOUSLY DISAPPEARED 1 TO 2 DAYS AFTER THE INJECTION. HOWEVER, A HEMATOMA SUBSEQUENTLY APPEARED ON HER LEFT EYELID. THE INJECTOR SCHEDULED A FOLLOW UP APPOINTMENT, BUT THE PATIENT DIDN'T COME. ON (B)(6) 2025, THE PATIENT CONTACTED HER INJECTOR AGAIN TO REPORT AN AREA OF HAIR LOSS RIGHT ABOVE THE LEFT TEMPLE. THE INJECTOR SCHEDULED A NEW CONSULTATION, B

  Patient problems: Erythema; Foreign Body Embolism; Hair Loss; Localized Skin Lesion; Skin Burning Sensation; Skin Discoloration

  MAUDE report 24289383 ↗