Recall Register

Food, drugs, devices › Firms

Solta Medical Inc

FDA recalling firm · 4 enforcement events · 5 product records · 2014–2023 · WA, CA

Solta Medical Inc has 4 FDA enforcement events on this register (5 product records) between 2014 and 2023: 4 device; the busiest year was 2014 with 1.

0% of its events are Class I; the most common class is Class II (4). 1 event is listed as ongoing; the recalling firm's address is in WA and CA.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

InitiatedProduct (first record)TypeClassRecordsStatus
16 Feb 2023thermage 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…DeviceClass II1Ongoing
30 Dec 2019Thermage 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.DeviceClass II1Terminated
1 Jun 2017VASER 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).DeviceClass II2Terminated
20 Mar 2014FRAXEL DUAL 1550/1927 Laser System, (FRAXEL SR 1500 DUAL Laser System), for dermatological procedures.DeviceClass II1Terminated

By type and class

Device4
Class II4

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

14
16
18
20
22
24
26
Enforcement events for Solta Medical Inc by year initiated.

Questions and answers

How many FDA recalls has Solta Medical Inc had?

4 enforcement events (5 product records) on this register, 2014–2023: 4 device.

Are any Solta Medical Inc recalls ongoing?

1 event is listed as ongoing in the current openFDA export.

What class are Solta Medical Inc recalls?

4 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.