RHA® 2 Mepi RHA® 2 Mepi - Terumo - USRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07640173233527), received between Oct 23, 2025 and May 28, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 28, 2026Off-Label Use; Improper or Incorrect Procedure or Method

  VASCULAR OCCLUSION [VASCULAR SKIN DISORDER] ([PALLOR], [LIVEDO RETICULARIS], [DISCOMFORT], [PAIN]) RHA2 IN THE CHIN [OFF LABEL USE] . CASE NARRATIVE: ON (B)(6) 2026, PRIMEVIGILANCE NOTIFIED TEOXANE GENEVA ABOUT AN ADVERSE EVENT FROM THE UNITED STATES. ACCORDING TO THE INFORMATION RECEIVED FROM THE INJECTOR, A PATIENT WAS INJECTED ON (B)(6) 2026 WITH 0.8 ML OF RHA 2 IN THE CHIN SHADOWING WITH A 30G NEEDLE. THE DAY (ON (B)(6) 2026), THE PATIENT NOTICED A BLANCHING OF THE SKIN ON PALPATION NEAR THE INJECTION SITE AND MASSAGED THE AREA. ON (B)(6) 2026, THE PATIENT EXPERIENCED TIGHTNESS, PAIN AND LIVEDO RETICULARIS (ALSO REPORTED BY THE PATIENT AS BRUISING). THE INJECTOR PRESCRIBED THE FOLLOWING TREATMENTS: MASSAGES APPLIED WARM COMPRESSES ASPIRIN (325 MG) THE SAME DAY, SHE ALSO RECEIVED HYALURONIDASE INJECTIONS (HYLENEX, 2 VIALS) AND FELT SLIGHT RELIEF. ON (B)(6) 2026, THE PATIENT RECEIVED AGAIN HYALURONIDASE INJECTIONS (HYLENEX, 2 VIALS). SHE FELT A LOT BETTER AND THE AREA WAS JUST SORE AND SLIGHTLY TENDER. SHE APPLIED A THIN LAYER OF NITRO PACE AND WAS INSTRUCTED TO LEAVE IT ON FOR AT LEAST SIX HOURS (NITRO BID NITROGLYCERIN OINTMENT 2%). THE PATIENT¿S CAPILLARY REFILL RETURNED TO NO

  Patient problems: Discomfort; Foreign Body Embolism; Pain; Skin Discoloration

  MAUDE report 25316154 ↗
• InjuryOct 23, 2025Off-Label Use; Improper or Incorrect Procedure or Method; Off-Label Use; Improper or Incorrect Procedure or Method

  VASCULAR OCCLUSION [VASCULAR SKIN DISORDER] RHA 2 MEPI IN THE LIPS [OFF LABEL USE] . CASE NARRATIVE: ON 02-OCT-2025, PRIMEVIGILANCE NOTIFIED TEOXANE GENEVA OF SEVERAL ADVERSE EVENTS. A SAME REPORTER REPORTED HAVING EPXRIENCED WITH HER STAFF, 3 VASCULAR OCCLUSIONS IN A WEEK USING RHA2 MEPI. HOWEVER, ONLY 2 PATIENTS COULD BE IDENTIFIED ON THE INFORMATION PROVIDED. FOR THIS REASON, 2 COMPLAINTS WERE OPENED (RC/2510014 AND RC/2510015) CONSIDERING A POSSIBLE TYPO. THE CURRENT COMPLAINT HAS BEEN OPENED FOR THE FIRST PATIENT. THE LATER HAD BEEN INJECTED ON (B)(6) 2025 WITH 0,5 ML OF RHA 2 MEPI IN THE LIPS WITH A NEEDLE. THE SAME DAY, THE PATIENT EXPERIENCED A VASCULAR OCCLUSION IN THE LIPS. DESPITE SEVERAL REMINDERS, NO FURTHER INFORMATION COULD BE RETRIEVED. THE COMPLAINT WAS CONSIDERED CLOSED. CASE COMMENTS: ALAM, M., KAKAR, R., DOVER, J., HARIKUMAR, V., KANG, B., WAN, H., POON, E. AND JONES, D., 2021. RATES OF VASCULAR OCCLUSION ASSOCIATED WITH USING NEEDLES VS CANNULAS FOR FILLER INJECTION.JAMA DERMATOLOGY, 157(2), P.174. CASSIANO, D., MIYUKI IIDA, T., LÚCIA RECIO, A. AND YARAK, S., 2020. DELAYED SKIN NECROSIS FOLLOWING HYALURONIC ACID FILLER INJECTION: A CASE REPORT.JOURNAL OF COSMET

  Patient problems: Foreign Body Embolism

  MAUDE report 23365291 ↗
• InjuryOct 23, 2025Off-Label Use; Improper or Incorrect Procedure or Method; Off-Label Use; Improper or Incorrect Procedure or Method

  VASCULAR OCCLUSION [VASCULAR SKIN DISORDER], RHA 2 MEPI IN THE LIPS [OFF LABEL USE] . CASE NARRATIVE: ON 02-OCT-2025, PRIMEVIGILANCE NOTIFIED TEOXANE GENEVA OF SEVERAL ADVERSE EVENTS. A SAME REPORTER REPORTED HAVING EPXRIENCED WITH HER STAFF, 3 VASCULAR OCCLUSIONS IN A WEEK USING RHA2 MEPI. HOWEVER, ONLY 2 PATIENTS COULD BE IDENTIFIED ON THE INFORMATION PROVIDED. FOR THIS REASON, 2 COMPLAINTS WERE OPENED (RC/2510014 AND RC/2510015) CONSIDERING A POSSIBLE TYPO. THE CURRENT COMPLAINT HAS BEEN OPENED FOR THE SECOND PATIENT. THE LATER HAD BEEN INJECTED DURING THE WEEK OF (B)(6) 2025 WITH RHA 2 MEPI AND EXPERIENCED A VASCULAR OCCLUSION IN THE LIPS (CURRENT COMPLAINT). DESPITE SEVERAL REMINDERS, NO FURTHER INFORMATION COULD BE RETRIEVED. THE COMPLAINT WAS CONSIDERED CLOSED. CASE COMMENTS: ¿ ALAM, M., KAKAR, R., DOVER, J., HARIKUMAR, V., KANG, B., WAN, H., POON, E. AND JONES, D., 2021. RATES OF VASCULAR OCCLUSION ASSOCIATED WITH USING NEEDLES VS CANNULAS FOR FILLER INJECTION.JAMA DERMATOLOGY, 157(2), P.174. CASSIANO, D., MIYUKI IIDA, T., LÚCIA RECIO, A. AND YARAK, S., 2020. DELAYED SKIN NECROSIS FOLLOWING HYALURONIC ACID FILLER INJECTION: A CASE REPORT.JOURNAL OF COSMETIC DERMATOLOGY, 19(

  Patient problems: Foreign Body Embolism

  MAUDE report 23365132 ↗