Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Solea Models 2.0 and 3.0 Laser Surgical Instrument Recalled by Convergent Dental Due to It has been found that potential unintended laser...

Date: September 1, 2023
Company: Convergent Dental
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Convergent Dental directly.

Affected Products

Solea Models 2.0 and 3.0 Laser Surgical Instrument, Foot Pedal assembly SUB-00434 with foot pedal CUS-00226 Rev. K reworked

Quantity: 39 units

Why Was This Recalled?

It has been found that potential unintended laser activation can occur without foot pedal depression.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Convergent Dental

Convergent Dental has 2 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report