JUVEDERM ULTRA XC 96207Recalls & reported problems
Allergan, Inc. · Juvéderm ULTRA XC 2x0.55mL · Class 3 · Implant
All models of JUVEDERM ULTRA XC (3)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10888628044760), received between Aug 20, 2026 and Aug 20, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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.
Reports received per month
Most reported problems
Device problems
- Improper or Incorrect Procedure or Method1
Patient problems
- Obstruction/Occlusion1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 20, 2026Improper or Incorrect Procedure or Method
A healthcare professional reported that a patient was injected with 0.1mL of JUVÉDERM® Ultra XC In the lip. 2 hours later, the patient experienced swelling and blanching in the upper right lip quadrant. The patient was treated with 3 rounds of hylanex, aspirin, a heat pad, BBL C02, and hyperbaric chamber therapy. The event fully resolved after one week.
Patient problems: Obstruction/Occlusion
MAUDE report 50349656 ↗
Other Implant, Dermal, For Aesthetic Use devices
- JUVEDERM VOLUMA XC 94640Allergan, Inc. · Implant, Dermal, For Aesthetic Use672 reports
- JUVEDERM ULTRA XC 94154Allergan, Inc. · Implant, Dermal, For Aesthetic Use541 reports
- JUVEDERM VOLLURE XC 95661Allergan, Inc. · Implant, Dermal, For Aesthetic Use380 reports
- JUVEDERM ULTRA PLUS XC 94155Allergan, Inc. · Implant, Dermal, For Aesthetic Use319 reports
- JUVÉDERM VOLBELLA XC 95834Allergan, Inc. · Implant, Dermal, For Aesthetic Use187 reports
- Skinvive 98307Allergan, Inc. · Implant, Dermal, For Aesthetic Use183 reports
- Revanesse Lips+ with Lidocaine 1.2 mL 40149Prollenium Medical · Implant, Dermal, For Aesthetic Use72 reports
- Radiesse (+) Lidocaine 8063M0K2Merz North America, Inc. · Implant, Dermal, For Aesthetic Use61 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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