EVOLYSSE SMOOTH EVOF1S001-SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03760172161301), received between Jan 6, 2026 and Apr 14, 2026 — classified as 4 injuries.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

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

  ON (B)(6) 2026, THE HCP REPORTED INJECTING 1 ML OF EVOLYSSE SMOOTH SUPERFICIALLY INTO THE SKIN AROUND THE MOUTH OF A PATIENT, USING THE PROVIDED 30-GAUGE NEEDLE. IMMEDIATELY FOLLOWING THE INJECTION, THE PATIENT EXPERIENCED DISCOLORATION IN THE LEFT ORAL COMMISSURE WITHOUT PAIN. THE HCP INJECTED THE AREA WITH 7 VIALS OF HYALURONIDASE, SYMPTOMS IMPROVED, AND CAPILLARY REFILL WAS NORMAL. HCP PRESCRIBED WARM COMPRESS AND MASSAGE. AS OF 10-APR-2026, THE PATIENTS SYMPTOMS HAVE RESOLVED.

  Patient problems: Obstruction/Occlusion; Skin Discoloration

  MAUDE report 24877541 ↗
• InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026, THE HCP REPORTED INJECTING 1 ML OF EVOLYSSE SMOOTH SUPERFICIALLY INTO THE SKIN AROUND THE MOUTH OF A PATIENT, USING THE PROVIDED 30-GAUGE NEEDLE. IMMEDIATELY FOLLOWING THE INJECTION, THE PATIENT EXPERIENCED DISCOLORATION IN THE LEFT ORAL COMMISSURE WITHOUT PAIN. THE HCP INJECTED THE AREA WITH 7 VIALS OF HYALURONIDASE, SYMPTOMS IMPROVED, AND CAPILLARY REFILL WAS NORMAL. HCP PRESCRIBED WARM COMPRESS AND MASSAGE. AS OF (B)(6) 2026, THE PATIENTS SYMPTOMS HAVE RESOLVED.

  Patient problems: Obstruction/Occlusion; Skin Discoloration

  MAUDE report 24877420 ↗
• InjuryJan 27, 2026Adverse Event Without Identified Device or Use Problem

  THE HEALTHCARE PROFESSIONAL REPORTED INJECTING EVOLYSSE SMOOTH SUBDERMALLY INTO THE CHEEKS OF A PATIENT ON (B)(6) 2025. THE PATIENT EXPERIENCED A HARD, RAISED, AND REDDENED AREA ON THE LEFT CHEEK. ON (B)(6) 2025, THE PATIENT EXPERIENCED A DECREASE IN THE SWELLING BUT THE AREA BECAME TENDER TO THE TOUCH. THEN ON (B)(6) 2025, THE PATIENT WAS DIAGNOSED WITH CELLULITIS AND PRESCRIBED KEFLEX.

  Patient problems: Bacterial Infection; Erythema; Local Reaction; Pain; Swelling/ Edema

  MAUDE report 24191575 ↗
• InjuryJan 6, 2026Adverse Event Without Identified Device or Use Problem

  THE HEALTHCARE PROFESSIONAL INJECTED EVOLYSSE SMOOTH SUBDERMALLY INTO A FEMALE PATIENT'S CHEEKS ON (B)(6) 2025. BY (B)(6) 2025, THE PATIENT DEVELOPED A SWOLLEN, PINK, AND TENDER AREA ON HER LEFT CHEEK. SHE CONSULTED A DIFFERENT DERMATOLOGIST AND WAS DIAGNOSED WITH CELLULITIS, FOR WHICH SHE RECEIVED A SEVEN-DAY COURSE OF KEFLEX. AFTER COMPLETING THE MEDICATION ON (B)(6) 2026, THE AFFECTED AREA FELT FIRM. ON (B)(6) 2026, THE AREA WAS TREATED WITH A 0.5ML INJECTION OF HYLENEX; AT THE PATIENT'S REQUEST, ANOTHER 1ML WAS INJECTED THE FOLLOWING DAY. BY (B)(6) 2026, THE FIRMNESS HAD MOVED LOWER ON HER LEFT CHEEK, PROMPTING ANOTHER 1ML INJECTION OF HYLENEX. AN INCONCLUSIVE CT SCAN WAS REPORTED ON (B)(6) 2026. THE PRIMARY CARE PHYSICIAN ADVISED DISCONTINUING PRODUCT DISSOLUTION AND PRESCRIBED ANOTHER ROUND OF KEFLEX. UPDATED PHOTOS SENT BY THE PROVIDER AFTER THE SECOND KEFLEX COURSE SHOWED THAT THE SWELLING AND REDNESS HAD RESOLVED AS OF (B)(6) 2026.

  Patient problems: Bacterial Infection

  MAUDE report 23979410 ↗