Morpheus8 Body (Blue) AG609126ARecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 07290016633672), received between Jun 19, 2023 and Aug 13, 2025 — classified as 15 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryAug 13, 2025Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  FULL THICKNESS BURN ON ABDOMEN OF A FEMALE PATIENT TREATED WITH MORPHEUS8.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 22791795 ↗
• InjuryMar 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PIH ON LOWER ABDOMEN 1 YEAR AND 3 MONTHS POST MORPHEUS8 TREATMENT.

  Patient problems: Hyperpigmentation

  MAUDE report 21676261 ↗
• InjuryMar 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PIE ON LOWER ABDOMEN 1 YEAR AND 1 MONTH POST MORPHEUS8 TREATMENT.

  Patient problems: Erythema

  MAUDE report 21676255 ↗
• InjurySep 18, 2024Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  FULL THICKNESS BURNS ON ANTERIOR NECK AND MANDIBLE.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 20246481 ↗
• InjurySep 18, 2024Use of Incorrect Control/Treatment Settings; Insufficient Device Problem Information; Use of Incorrect Control/Treatment Settings; Insufficient Device Problem Information

  FULL THICKNESS BURNS ON GLUTEAL FOLD AND THIGHS.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 20246410 ↗
• InjurySep 11, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  PIE AND PIH ON ABDOMEN 8 MONTHS POST MORPHEUS8 TREATMENT.

  Patient problems: Erythema; Hyperpigmentation

  MAUDE report 20188834 ↗
• InjuryJun 19, 2024Use of Incorrect Control/Treatment Settings; Insufficient Device Problem Information; Use of Incorrect Control/Treatment Settings; Insufficient Device Problem Information

  FULL THICKNESS BURNS ON UPPER ARMS POST MORPHEUS8 TREATMENT.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 19565754 ↗
• InjuryJun 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFLAMMATORY REACTION ON THE ABDOMEN WITH PIE/PIH 4 MONTHS POST MORPHEUS8 TREATMENT.

  Patient problems: Erythema; Hyperpigmentation; Skin Inflammation/ Irritation

  MAUDE report 19466019 ↗
• InjuryNov 9, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  PIE WITH TIP FOOTPRINT PATTERN ON BOTH ANTERIOR THIGHS 6 MONTHS AFTER MORHEUS8 TREATMENT.

  Patient problems: Erythema

  MAUDE report 18098938 ↗
• InjuryNov 1, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  PIE ON ABDOMEN WITH TIP FOOTPRINTS PATTERN 11 MONTHS AFTER MORPHEUS8 TREATMENT.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 18048292 ↗
• InjuryAug 22, 2023Use of Incorrect Control/Treatment Settings; Use of Incorrect Control/Treatment Settings

  PIE ON ABDOMEN 1 YEAR POST TREATMENT.

  Patient problems: Erythema; Hyperpigmentation

  MAUDE report 17593612 ↗
• InjuryJul 24, 2023Use of Incorrect Control/Treatment Settings; Use of Incorrect Control/Treatment Settings

  A WIDESPREAD POST-INFLAMMATORY ERYTHEMATOUS STATE OVER THE ENTIRE FACE AND NECK 7 MONTHS AFTER TREATMENT WITH M8. THE FOOTPRINTS IN THE SHAPE OF THE TIP MATRIX ARE OBSERVABLE. POST-INFLAMMATORY HYPERPIGMENTATION IS ALSO VISIBLE AT THE NEEDLE INSERTION POINTS. THE CLINICAL PICTURE WOULD APPEAR TO BE A COMPROMISED AND ALTERED HEALING PROCESS. ACCORDING TO THE UPDATED INFORMATION RECEIVED FROM THE PATIENT, THE PIE REACTION HAS NOT SUBSIDED AFTER 7 MONTHS. DUE TO THE LONGEVITY OF THE REACTION, IT WAS DECIDED TO REPORT THIS EVENT.

  Patient problems: Erythema; Hyperpigmentation

  MAUDE report 17379134 ↗
• InjuryJul 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PROLONGED INTENSE PIE IN THE ABDOMINAL AREA AFTER ONE TREATMENT WITH M8 AT 6 MONTHS AFTER TREATMENT.

  Patient problems: Erythema

  MAUDE report 17255608 ↗
• InjuryJun 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  3 ULCERATIVE LESIONS 3 WEEKS FOLLOWING M8 BODY TX, ONE OF WHICH ABOUT 2 CM IN DIAMETER LOCATED IN THE MEDIAL ASPECT OF THE LEFT THIGH. CRUST FORMATION AND INFLAMED CONTOURS ARE OBSERVED. 2 OTHER SMALLER ULCERATIVE LESIONS, EACH ABOUT 1 CM IN DIAMETER, LOCATED RESPECTIVELY ON THE MEDIAL ASPECT OF THE RIGHT THIGH. ALSO HERE, ESCHAR FORMATIONS AND INFLAMED (POSSIBLY INFECTED) CONTOURS ARE OBSERVED. THE LESIONS PRESENT ULCERATIVE CRATERS, APPARENTLY QUITE DEEP WITH INVOLVEMENT OF THE DERMAL RETICULAR TISSUE. FIBROTIC SCARRING CANNOT BE RULED OUT AT THE MOMENT.

  Patient problems: Localized Skin Lesion

  MAUDE report 17150332 ↗
• InjuryJun 19, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  INFLAMED RECTANGULAR SKIN REACTIONS REPRODUCING THE NEEDLE MATRIX OF THE TIP SCATTERED THROUGHOUT THE ENTIRE ABDOMINAL AREA IN THE HYPOGASTRIC, UMBILICAL AND EPIGASTRIC REGIONS. THIS REACTION PERSISTS 2 MONTHS AFTER THE TREATMENT PERFORMED WITH MORPHEUS 8. ERYTHEMATOUS-PAPULAR LESIONS ARE OBSERVED CORRESPONDING TO THE NEEDLE INSERTIONS STILL IN INFLAMMATORY PHASE. GIVING A FIRST LOOK AT THE SETTING USED DURING THE TREATMENT IT SEEMS EXCESSIVE AND NOT COMPLIANT WITH THE PROTOCOL. THIS LEVEL OF INTENSITY CHARACTERIZES A FIRST AND IMMEDIATE SKIN REACTION. ALTHOUGH THE NATURE OF THE LESIONS IS TO BE CONSIDERED SUPERFICIAL AND REVERSIBLE, SUCH LONG-TERM PERMANENCE OF THIS STAGE IS NOT EXPECTED AND THEREFORE IT IS DECIDED TO REPORT THE EVENT TO THE COMPETENT AUTHORITIES.

  Patient problems: Erythema

  MAUDE report 17149820 ↗