FDA Medical devices recall ·
Aerin Medical VivAer Stylus recall
- Recall number
- Z-0808-2025
- Date
- (initiated November 12, 2024)
- Company / brand
- Aerin Medical, Inc.
232 E Caribbean Dr, Sunnyvale, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 479 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Aerin Medical VivAer Stylus, REF CAT1785 (individual stylus), and REF CAT500 (5-pack), sterile.
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot #10235, exp. 2026-05-01; UDI (01)08886479300269(17)260501(10)10235
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.
States: Alabama Arizona California Colorado Georgia Idaho Illinois Indiana Kentucky Louisiana Michigan Minnesota Nebraska New York Ohio Oregon Pennsylvania South Carolina Tennessee Texas Utah Virginia Washington Wisconsin West Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0808-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.