# FDA recall Z-0808-2025

> **Aerin Medical, Inc.** · Class II · device recall initiated 2024-11-12.

## 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.

## 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.

## Key facts

- **Recall number:** Z-0808-2025
- **Recalling firm:** Aerin Medical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-11-12
- **Report date:** 2025-01-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Sunnyvale, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0808-2025

## Citation

> AI Analytics. FDA recall Z-0808-2025. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0808-2025. Source: US FDA. Licensed CC0.

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