Solta Medical Inc 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Solta Medical Inc
Lot Codes / Batch Numbers
Model Number /Lot Numbers: TTNS3.00C3-400: DOM 120519 011, DOM 120419 014, DOM 120219 008, DOM 112619 006, DOM 112019 010, DOM 111519 004, DOM 100819 005, DOM 100119 005, DOM 082319 003, DOM 081919 007, DOM 081419 004, TTNS3.00C3-600: DOM 120419 018, DOM 112019 009, DOM 110119 010, DOM 092319 005, DOM 082219 015, DOM 082119 006, TTNS3.00C3-900: DOM 111819 005, DOM 092319 006, DOM 081419 005 Lot number/Number of Units Affected 120219-008/180, 112619-006/225, 112019-010/225, 112019-009/420, 111519-004/220, 110119-010/398, 100819-005/405, 092319-006/23, 092319-005/342, 082319-003/525, 082219-015/504, 082119-006/252, 081419-007/135, 081419-005/126, 081419-004/492 REF/UDI: TTNS3, 00C3-400/UDI (01)000850608002377, REF TTNS3.00C3-600/UDI (01)000850608002384, REF TTNS3.00C3-900, UDI (01)000850608002391
Products Sold
Model Number /Lot Numbers: TTNS3.00C3-400: DOM 120519 011, DOM 120419 014, DOM 120219 008, DOM 112619 006, DOM 112019 010, DOM 111519 004, DOM 100819 005, DOM 100119 005, DOM 082319 003, DOM 081919 007, DOM 081419 004; TTNS3.00C3-600: DOM 120419 018, DOM 112019 009, DOM 110119 010, DOM 092319 005, DOM 082219 015, DOM 082119 006; TTNS3.00C3-900: DOM 111819 005, DOM 092319 006 , DOM 081419 005 Lot number/Number of Units Affected 120219-008/180, 112619-006/225, 112019-010/225, 112019-009/420, 111519-004/220, 110119-010/398, 100819-005/405, 092319-006/23, 092319-005/342, 082319-003/525, 082219-015/504, 082119-006/252, 081419-007/135, 081419-005/126, 081419-004/492 REF/UDI: TTNS3,00C3-400/UDI (01)000850608002377; REF TTNS3.00C3-600/UDI (01)000850608002384; REF TTNS3.00C3-900; UDI (01)000850608002391
Solta Medical Inc is recalling Thermage Face Tip 3.0, REF/UDI: TTNS3,00C3-400/UDI (01)000850608002377; REF TTNS3.00C3-600/UDI (01)0 due to Complaints of sparking of the tips of the electrosurgical device used in RF surgical procedures. The use of the affected treatment tips could contribu. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Complaints of sparking of the tips of the electrosurgical device used in RF surgical procedures. The use of the affected treatment tips could contribute to potential skin burns.
Recommended Action
Per FDA guidance
On 12/30/2019, the firm sent an "URGENT VOLUNTARY MEDICAL DEVICE RECALL" to customers via registered mail to inform them that they have become aware that there is a potential problem related to their device that may result in patient burns. This recall affects 20 lots manufactured and distributed between 08/14/2019 and 12/12/2019. The firm is instructing the customers to: 1. Review their inventory for all devices impacted by this voluntary recall and remove them from the inventory. 2. The manufacturer/ recalling firm is asking their customers to contact Customer Service at 1-877-782-2286 option 1 to arrange the return of the impacted devices in the inventory. 3. In addition, the firm is requesting the customers to complete the enclosed Product Recall Acknowledgement Form and return it to the manufacturer via email at orders@solta.com or fax at 1-800-685-6430 within 5 days. Solta Customer Service has followed up with customers via phone call and/or email.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AK, AZ, AR, CA, FL, GA, IL, NY, PA, TX, UT, WA
Page updated: Jan 10, 2026