Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Thermage Face Tip 3.0 Recalled by Solta Medical Inc Due to Complaints of sparking of the tips of the...

Date: December 30, 2019
Company: Solta Medical Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Solta Medical Inc directly.

Affected Products

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.

Quantity: 4472 units

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed to 12 states: AK, AZ, AR, CA, FL, GA, IL, NY, PA, TX, UT, WA

Affected (12 states)Not affected

About Solta Medical Inc

Solta Medical Inc has 4 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report