Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Aerin Medical VivAer Stylus Recalled by Aerin Medical, Inc. Due to Some units in a single production lot were...
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 Aerin Medical, Inc. directly.
Affected Products
Aerin Medical VivAer Stylus, REF CAT1785 (individual stylus), and REF CAT500 (5-pack), sterile.
Quantity: 479 units
Why Was This Recalled?
Some units in a single production lot were programmed incorrectly which will result in the VivAer Stylus being incorrectly recognized as RhinAer Stylus when connected to the Aerin Console.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Aerin Medical, Inc.
Aerin Medical, 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