Reported Jan 15, 2025 · Ongoing

Aerin Medical VivAer Stylus, REF CAT1785 (individual stylus), and REF CAT500 (5-pack), sterile.

Aerin Medical, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Aerin Medical, Inc. · 232 E Caribbean Dr · Sunnyvale, CA · 94089-1007

Is this the product you have?

  • Aerin Medical VivAer Stylus, REF CAT1785 (individual stylus), and REF CAT500 (5-pack), sterile.
Lot codes and dates
    • Lot #10235
    • exp. 2026-05-01
    • UDI (01)08886479300269(17)260501(10)10235
Amount recalled
479 units

Where it was sold

Why it was 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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 4:54 PM UTC

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