The Recall Desk

Manufacturer

Solta Medical, Inc.

5 recalls in our database name Solta Medical, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
5
Critical
0
Severe
1
Most recent
2023-04-19

Of the 5 recalls from Solta Medical, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (20%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–5 of 5

  • ModerateFDA (Devices)·Z-1354-2023·2023-04-19

    Thermage CPT System unit improperly tested and calibrated during manufacturing

    Solta Medical is recalling one Thermage CPT System unit that was potentially improperly tested and calibrated during manufacturing. The company is contacting the affected customer regarding corrective action.

    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 u
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1681-2020·2020-04-15

    Solta Medical Recalls Thermage Face Tips Due to Sparking and Burn Risk

    Solta Medical is recalling Thermage Face Tip 3.0 units because sparking during use could cause 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.
    Category
    Medical Device
    Distribution
    12 states
  • SevereFDA (Devices)·Z-3047-2017·2017-08-30

    Solta Medical Recalls VASER Amplifiers Due to Burn Risk

    Solta Medical is recalling four VASER Amplifier units because a service depot repair may have caused inaccurate calibration, posing a burn risk to patients.

    Product
    VASER Amplifier, VASER 2.2 VASERlipo System, Rx Only, 115/230V - 60/50Hz 300VA The Vaser amplifier is intended for the fragmentation and emulsification of subcutaneous fatty tissues for aesthetic body contouring (modification of the anatomy).
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-3048-2017·2017-08-30

    Solta Medical Recalls VASER PRO Amplifiers Due to Burn Risk

    Solta Medical is recalling seven VASER PRO Amplifiers because a service depot repair may have caused inaccurate calibration, posing a risk of patient burns.

    Product
    VASER PRO Amplifier, VASER 2.2 VASERlipo System stem, Rx Only, 115/230V - 60/50Hz 300VA The Vaser amplifier is intended for the fragmentation and emulsification of subcutaneous fatty tissues for aesthetic body contouring (modification of the anatomy).
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1463-2014·2014-04-23

    Solta Medical Recalls Fraxel DUAL Laser Systems Due to Incorrect Labeling

    Solta Medical is recalling 1,077 Fraxel DUAL 1550/1927 Laser Systems because obsolete treatment cards may contain incorrect indications for treating Melasma.

    Product
    FRAXEL DUAL 1550/1927 Laser System, (FRAXEL SR 1500 DUAL Laser System), for dermatological procedures.
    Category
    Medical Device
    Distribution
    0 states