Class II — Solta Medical Inc
| Recalling firm | Solta Medical |
|---|---|
| Registered facility | Solta Medical, Inc. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | A service unit was potentially improperly tested and calibrated during manufacturing on a failed test station. |
| Product | thermage THERMAGE CPT SYSTEM REF TG-2B *** Solta Medical, Inc. thermage RF GENERATOR REF TG-2B *** Solta Medical, Inc. Dermatologic and general surgical procedures for electrocoagulation and hemostasis; " Non-invasive treatment of periorbital wrinkles and rhytids including upper and lower eyelids; " Non-invasive treatment of wrinkles and rhytids. The Thermage CPT System ( System ) consists of the RF Generator/ Cooling System, 16.00 cm2 Handpiece ( Body Handpiece ), Standard Handpiece with Vibration ( Face Handpiece ), optional electric Footswitch, accessory cables, Return Pad, Return P… |
| Quantity | 1 unit |
| Distribution | U.S. Distribution to state of: MD |
| Initiated | 2023-02-16 |
| Classified | 2023-04-07 |
| Recall number | Z-1354-2023 |
| 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-1354-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/91847/
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