Aerin Medical VivAer Stylus — Class II medical device recall Z-0808-2025
Ongoing recall by Aerin Medical, Inc., reported 2025-01-15, distributed nationwide. Some units in a single production lot were programmed incorrectly which will result in the VivAer Stylus being
| Recall number | Z-0808-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aerin Medical, Inc., Sunnyvale, CA, United States |
| Recall initiated | 2024-11-12 |
| Classified | 2025-01-06 |
| Reported by FDA | 2025-01-15 |
| Distributed | Nationwide (US) |
| Quantity | 479 units |
| UPC / GTIN / UDI-DI | 08886479300269 |
| Lot numbers | 10235 |
| Model numbers | 1785, 500 |
| Expiration dates | 2026-05-01 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0808-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.