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

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: US Nationwide Distribution: AL, AZ, CA, CO, GA, ID, IL, IN, KY LA, MI, MN, NY, NE, NY, OH, OR PA, SC, TN, TX, UT, VA, WA, WI, and WV. Quantity: 479 units Lot/code info: Lot #10235, exp. 2026-05-01; UDI (01)08886479300269(17)260501(10)10235

UPC codes

08886479300269

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.