Solta Medical Inc: Medical Device Recall in 2023 - (Recall #: Z-1354-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: February 16, 2023

Date Posted: April 19, 2023

Recall Number: Z-1354-2023

Event ID: 91847

Reason for Recall:

A service unit was potentially improperly tested and calibrated during manufacturing on a failed test station.

Status: Ongoing

Product Quantity: 1 unit

Code Information:

Model Number: TG-2B UDI-DI Code: 00850608002124 Serial Number: 001933

Distribution Pattern:

U.S. Distribution to state of: MD

Voluntary or Mandated:

Voluntary: Firm initiated