---
title: "thermage THERMAGE CPT SYSTEM REF TG-2B *** Solta Medical, Inc. thermage RF GE... — FDA record Z-1354-2023 | Is It on Recall"
description: "A service unit was potentially improperly tested and calibrated during manufacturing on a failed test station."
url: https://isitonrecall.com/recall/fda-device-z-1354-2023-thermage-thermage-cpt-system-ref-tg-2b-solta-medical-inc-thermage-rf-generator-ref-tg-2b-solta-medic/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# thermage THERMAGE CPT SYSTEM REF TG-2B \*\*\* Solta Medical, Inc. thermage RF GENERATOR REF TG-2B \*\*\* Solta Medical, Inc... — FDA record Z-1354-2023

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Feb 16, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **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**: A service unit was potentially improperly tested and calibrated during manufacturing on a failed test station.
- **Classification**: Class II
- **Recalling firm**: Solta Medical Inc
- **Quantity**: 1 unit
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-1354-2023

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1354-2023%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | Model Number: TG-2B UDI-DI Code: 00850608002124 Serial Number: 001933 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

U.S. Distribution to state of: MD

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [Maryland](https://isitonrecall.com/state/maryland/)

## Dates in the source

- **Report date**: Apr 19, 2023
- **Recall initiation date**: Feb 16, 2023
- **Center classification date**: Apr 7, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1354-2023%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Solta Medical Inc records](https://isitonrecall.com/brand/solta-medical-inc/)