Recall Z-0808-2025— Aerin Medical, Inc.
Class II · Ongoing
Class II FDA medical device recall by Aerin Medical, Inc., initiated 2024-11-12. It names one FDA 510(k) clearance: K200300. Product: Aerin Medical VivAer Stylus, REF CAT1785 (individual stylus), and REF CAT500 (5-pack), sterile.. Reason: 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..
- Recalling firm
- Aerin Medical, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-11-12
- Firm location
- Sunnyvale, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.