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 #10235exp. 2026-05-01UDI (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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