FDA recall Z-0808-2025

Aerin Medical, Inc. · Class II · device

Product

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

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.

Key facts

Status: Ongoing
Initiation date: 2024-11-12
Report date: 2025-01-15
Voluntary/Mandated: Voluntary: Firm initiated
Location: Sunnyvale, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0808-2025