Aerin Medical, Inc.: Device Recall
Recall #Z-0808-2025 · 11/12/2024
Class II: Risk
Recall Details
- Recall Number
- Z-0808-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Aerin Medical, Inc.
- Status
- Ongoing
- Date Initiated
- 11/12/2024
- Location
- Sunnyvale, CA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 479 units
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.
Product Description
Aerin Medical VivAer Stylus, REF CAT1785 (individual stylus), and REF CAT500 (5-pack), sterile.
Distribution Pattern
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.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.