thermage THERMAGE CPT SYSTEM REF TG-2B *** Solta Medical — Class II medical device recall Z-1354-2023
Ongoing recall by Solta Medical Inc, reported 2023-04-19. A service unit was potentially improperly tested and calibrated during manufacturing on a failed test station.
| Recall number | Z-1354-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Solta Medical Inc, Bothell, WA, United States |
| Recall initiated | 2023-02-16 |
| Classified | 2023-04-07 |
| Reported by FDA | 2023-04-19 |
| Quantity | 1 units |
| UPC / GTIN / UDI-DI | 00850608002124 |
| Serial numbers | 001933 |
| Model numbers | TG-2B |
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 Pad Cable, and Treatment Tips.
Reason for recall
A service unit was potentially improperly tested and calibrated during manufacturing on a failed test station.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1354-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.