JUVEDERM VOLBELLA XC 1ML SAMPLE 96181DBRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10840228302794), received between May 13, 2026 and Sep 23, 2026 — classified as 5 injuries.

The most frequently reported specific device problem is “Off-Label Use” (1 report).

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

• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Subcutaneous Nodule

  MAUDE report 50874567 ↗
• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  A healthcare professional reported that 1 mL of JUVÉDERM® VOLUMA¿ XC in the chin, 0.5 mL of JUVÉDERM® VOLBELLA¿ XC in the lips, and 1 mL of JUVÉDERM® Ultra XC. The patient experienced one large, delayed onset nodules on both sides of chin, two small, delayed onset nodules on the left lower lip, and three small, delayed onset nodules on the left upper lip. Recently the HCP reported performing a physical examination and treating patient with 5-FU. This was the initial use of the syringe. An additional follow-up will be provided. Symptoms are ongoing.Additionally, the patient reported an adverse event with an unspecified JUVÉDERM® XC product and stated that a healthcare professional was asked to evaluate the lumps. The patient reported four areas of delayed-onset granulomas on the face following treatment approximately five months earlier, involving the upper lip, lower lip, and chin. The patient¿s lips were injected with JUVÉDERM VOLBELLA® XC, and the chin was injected with JUVÉDERM VOLUMA® XC. The HCP injected a product to help reduce swelling, and the patient was also prescribed Zyrtec and Pepcid.

  Patient problems: Subcutaneous Nodule

  MAUDE report 50809267 ↗
• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  A healthcare professional reported that 1 mL of JUVÉDERM® VOLUMA¿ XC in the chin, 0.5 mL of JUVÉDERM® VOLBELLA¿ XC in the lips, and 1 mL of JUVÉDERM® Ultra XC. The patient experienced one large, delayed onset nodules on both sides of chin, two small, delayed onset nodules on the left lower lip, and three small, delayed onset nodules on the left upper lip. Recently the HCP reported performing a physical examination and treating patient with 5-FU. This was the initial use of the syringe. An additional follow-up will be provided. Symptoms are ongoing.Additionally, the patient reported an adverse event with an unspecified JUVÉDERM® XC product and stated that a healthcare professional was asked to evaluate the lumps. The patient reported four areas of delayed-onset granulomas on the face following treatment approximately five months earlier, involving the upper lip, lower lip, and chin. The patient¿s lips were injected with JUVÉDERM VOLBELLA® XC, and the chin was injected with JUVÉDERM VOLUMA® XC. The HCP injected a product to help reduce swelling, and the patient was also prescribed Zyrtec and Pepcid.

  Patient problems: Subcutaneous Nodule

  MAUDE report 50809247 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  Healthcare professional reported that a patient was injected 0.55 cc in the lips with JUVÉDERM® VOLBELLA¿ XC, "Patient has late onset nodules". Later physician reported "unilateral swelling/nodule on right lip, where a small hard nodule is observed; patient has depression". A course of Benadryl was prescribed as treatment. The event is ongoing.

  Patient problems: Nodule

  MAUDE report 50010283 ↗
• InjuryMay 13, 2026Off-Label Use

  A HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT ONE YEAR AGO WAS INJECTED IN THE FOREHEAD WITH JUVÉDERM VOLBELLA® XC. A LITTLE UNDER A YEAR THE PATIENT WAS PRESENTED WITH NODULES. THERE WAS NO PAIN OR REDNESS. THE HEALTHCARE PROFESSIONAL PRESCRIBED THE PATIENT WITH 2 VIALS OF HYLENEX. THE PATIENT RETURNED AND THE HYLENEX WAS ADMINISTERED AS WELL AS A MASSAGE. THE SYMPTOMS ARE NOT RESOLVED.

  Patient problems: Subcutaneous Nodule

  MAUDE report 25160378 ↗