Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Cellfina Prep Pack Recalled by Ulthera Inc Due to It was discovered that a non-sterile vacuum tube...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Ulthera Inc directly.
Affected Products
Cellfina Prep Pack, Part No. CP1
Quantity: 6562 units
Why Was This Recalled?
It was discovered that a non-sterile vacuum tube is supplied within the pack, although the Instructions for Use (IFU) describe the use of a sterile vacuum tube as part of the procedure setup.
Where Was This Sold?
Worldwide Distribution - US Distribution and to the countries of :Europe (Austria, France, Germany, Italy, Netherlands, Switzerland, Spain, UK)
About Ulthera Inc
Ulthera Inc has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report