Thermage Face Tip 3 — Class II medical device recall Z-1681-2020

Terminated recall by Solta Medical Inc, reported 2020-04-15, distributed in AK, AR, AZ, CA, FL, GA, IL, NY…. Complaints of sparking of the tips of the electrosurgical device used in RF surgical procedures. The use of th

Recall number	`Z-1681-2020`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Solta Medical Inc, Bothell, WA, United States
Recall initiated	2019-12-30
Classified	2020-04-07
Reported by FDA	2020-04-15
Terminated	2024-04-29
Distributed	AK, AR, AZ, CA, FL, GA, IL, NY, PA, TX, UT, WA
Countries outside the US	JP, KR, MY, SG, TH, TW
Quantity	4,472 units
Lot numbers	`003`, `004`, `005`, `006`, `007`, `008`, `009`, `010`, `011`, `014`, `015`, `018`, `081419`, `081919`, `082119`, `082219`, `082319`, `092319`, `100119`, `100819`, `110119`, `111519`, `111819`, `112019`, `112619`, `120219`, `120419`, `120519`, `TTNS3.00C3-400`, `TTNS3.00C3-600`, `TTNS3.00C3-900`
Model numbers	`TTNS3.00C3-600`, `TTNS3.00C3-900`

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.

Reason for recall

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1681-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.