Z-0808-2025 Class II Ongoing
FDA device recall Z-0808-2025 was initiated by Aerin Medical, Inc. on November 12, 2024 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 479 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 15, 2025
- Initiation Date
- November 12, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 479 units
Product Description
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 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.
Code Information
Lot #10235, exp. 2026-05-01; UDI (01)08886479300269(17)260501(10)10235