medical Class II Updated 2025-01-15

Aerin Medical, Inc. recalls Aerin Medical VivAer Stylus, REF CAT1785 (individual stylus)

Recalled Product

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

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot #10235, exp. 2026-05-01; UDI (01)08886479300269(17)260501(10)10235
View official government recall

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