InMode RF™ InMode RF™ Black-GreyRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 07290016633337), received between Mar 23, 2023 and Feb 25, 2026 — classified as 12 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (7 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 25, 2026Use of Device Problem; Insufficient Device Problem Information

  DOCTOR REPORTED TO INMODE REPRESENTATIVE ABOUT A PATIENT SUSTAINING "FULL THICKNESS BURNS ON THE LOWER FACIAL NASOLABIAL FOLD AREA AND 4 BURNS PER ARM". THE PROVIDED PHOTOS SHOWED A FEMALE PATIENT WITH A LINEAR SCAR OF ~1.5CM IN LENGTH NEAR THE LEFT MARIONETTE FOLD, PRECEDED BY A FULL THICKNESS BURN, FOLLOWING FACETITE PROCEDURE.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 24442044 ↗
• InjuryDec 15, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  FULL THICKNESS BURNS WITH NECROSIS, DISFIGUREMENT, AND SCARRING FOLLOWING ABDOMINOPLASTY, LIPOSUCTION AND BODYTITE PROCEDURES.

  Patient problems: Deformity/ Disfigurement; Full thickness (Third Degree) Burn; Necrosis; Scar Tissue

  MAUDE report 23802038 ↗
• InjuryNov 6, 2025Use of Device Problem; Use of Device Problem

  NEURAPRAXIA AFTER FACETITE TREATMENT.

  Patient problems: Peripheral Nervous Injury

  MAUDE report 23484217 ↗
• InjurySep 3, 2025Improper or Incorrect Procedure or Method; Insufficient Device Problem Information; Improper or Incorrect Procedure or Method; Insufficient Device Problem Information

  NECROSIS POST FULL THICKNESS BURN NEAR THE KNEE POST BODYTITE PROCEDURE.

  Patient problems: Full thickness (Third Degree) Burn; Necrosis

  MAUDE report 22949818 ↗
• InjuryJul 15, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  FIBROSIS AND NEUROPATHY ON ABDOMEN FOLLOWING BODYTITE PROCEDURE.

  Patient problems: Fibrosis; Neuropathy

  MAUDE report 22505118 ↗
• InjuryFeb 13, 2025Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  FULL THICKNESS BURN ON ARM POST BODYTITE PROCEDURE.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 21372426 ↗
• InjuryOct 20, 2024Use of Device Problem; Use of Device Problem

  BURNS ON THIGHS AND SCARRING POST BODYTITE PROCEDURE.

  Patient problems: Full thickness (Third Degree) Burn; Scar Tissue

  MAUDE report 20489781 ↗
• InjuryJul 23, 2024Use of Device Problem; Use of Device Problem

  NEUROPRAXIA OF UPPER LIP.

  Patient problems: Nerve Damage

  MAUDE report 19803552 ↗
• InjuryJun 30, 2024Use of Device Problem; Use of Device Problem

  TRANSIENT PARESIS AFTER FACETTE AND MORPHEUS 8 TREATMENT.

  Patient problems: Nerve Damage

  MAUDE report 19640801 ↗
• InjuryJun 30, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  NEUROPRAXIA OF UPPER LIP.

  Patient problems: Nerve Damage

  MAUDE report 19640779 ↗
• InjuryMar 27, 2024Use of Device Problem; Use of Device Problem

  HARD PURPLISH NODULE ON LEFT THIGH IN A FEMALE PATIENT TREATED WITH BODYTITE BILATERALLY IN (B)(6) 2022 FOR SKIN LAXITY.

  Patient problems: Scar Tissue

  MAUDE report 18985014 ↗
• InjuryMar 23, 2023Improper or Incorrect Procedure or Method; Insufficient Device Problem Information; Improper or Incorrect Procedure or Method; Insufficient Device Problem Information

  LEFT POSTERIOR UPPER ARM BURNED WHILE USING BODYTITE TECHNOLOGY.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 16597458 ↗