Class II — Solta Medical Inc
| Recalling firm | Solta Medical |
|---|---|
| Registered facility | Solta Medical, Inc. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| 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. |
| Quantity | 4472 units |
| Distribution | US - AK, AR, AZ, CA, FL, GA, IL, NY, PA, TX. UT, and WA OUS -Japan, Korea, Malaysia, Singapore, Taiwan, and Thailand. |
| Initiated | 2019-12-30 |
| Classified | 2020-04-07 |
| Terminated | 2024-04-29 |
| Recall number | Z-1681-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Solta Medical Inc (Z-1681-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/85314/
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