# FDA recall Z-1681-2020

> **Solta Medical Inc** · Class II · device recall initiated 2019-12-30.

## Product

Thermage Face Tip 3.0, REF/UDI: TTNS3,00C3-400/UDI (01)000850608002377; REF TTNS3.00C3-600/UDI (01)000850608002384; REF TTNS3.00C3-900; UDI (01)000850608002391  Used in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

## Reason for recall

Complaints of sparking of the tips of the electrosurgical device used in RF surgical procedures. The use of the affected treatment tips could contribute to potential skin burns.

## Distribution

US - AK, AR, AZ, CA, FL, GA, IL, NY, PA, TX. UT, and WA    OUS -Japan, Korea, Malaysia, Singapore, Taiwan, and Thailand.

## Key facts

- **Recall number:** Z-1681-2020
- **Recalling firm:** Solta Medical Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-12-30
- **Report date:** 2020-04-15
- **Termination date:** 2024-04-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bothell, WA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1681-2020

## Citation

> AI Analytics. FDA recall Z-1681-2020. Retrieved 2026-07-17 from https://api.ai-analytics.org/recall/Z-1681-2020. Source: US FDA. Licensed CC0.

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