Go Backs
HomeCategoriesStatesCheck Your Home
Go Backs

Track product recalls and safety alerts from CPSC, FDA, NHTSA, and USDA. Stay informed and keep your family safe.

Browse

  • Categories
  • States
  • Check Your Home
  • Risk Levels

Agencies

  • CPSC
  • FDA Food
  • FDA Drug
  • FDA Device
  • FDA Veterinary
  • NHTSA
  • USDA

Company

  • About
  • FAQ
  • Contact
  • Terms of Service
  • Privacy Policy
Buy Me a Coffee

Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

ยฉ 2026 Go Backs. All rights reserved.

Medium RiskFDA Device
Medical Devices/Surgical Equipment

Convergent Dental: Solea Dental Laser Surgical Instruments Recalled for Unintended Activation

Agency Publication Date: November 17, 2023
Share:
Sign in to monitor this recall

Summary

Convergent Dental is recalling 39 units of Solea Models 2.0 and 3.0 Laser Surgical Instruments because the laser can activate unexpectedly without the user pressing the foot pedal. This issue affects specific units equipped with a reworked foot pedal assembly (Model CUS-00226 Rev. K). These dental lasers were distributed nationwide across 20 states and in Canada. Consumers should identify their device by checking the serial number and contact the manufacturer immediately for guidance.

Risk

The laser may activate without warning or pedal depression, which could lead to accidental laser exposure or injury to the patient or dental staff during a procedure.

What You Should Do

  1. Check your device's model and serial number to see if it is included in this recall. Affected Solea Model 3.0 units have UDI-DI 00850634007018 and serial numbers: 0310516, 0310517, 0310518, 0310519, 0310520, 0310521, 0310522, 0310523, 0310524, 0310525, 0310526, 0310527, 0310528, 0310529, 0310530, 0310531, 0310532, 0310533, 0310534, 0310535, 0310536, 0310537, 0310538, 0310539, 0310540, 0310541, 0310542, 0310543, 0310317, 0310321, 0310322, or 0300730.
  2. Identify if you have an affected Solea Model 2.0 unit by checking for UDI-DI 00850634007001 and serial numbers: 0200822, 0200807, 0200810, 0200625, CDS2-U33W-1B-DE-15, 0200819, or 0200401.
  3. Verify if your device uses Foot Pedal assembly SUB-00434 with foot pedal CUS-00226 Rev. K (reworked).
  4. Contact your healthcare provider or Convergent Dental at their headquarters in Needham, Massachusetts, for further instructions on how to handle the device and to arrange for a potential repair or refund.
  5. Contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls if you have additional questions regarding medical device safety.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer initiated recall via letter notification.

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Solea Model 3.0 Laser Surgical Instrument
Model / REF:
Solea Model 3.0
Foot Pedal assembly SUB-00434
Foot pedal CUS-00226 Rev. K
UPC Codes:
00850634007018
Lot Numbers:
0310516
0310517
0310518
0310519
0310520
0310521
0310522
0310523
0310524
0310525
0310526
0310527
0310528
0310529
0310530
0310531
0310532
0310533
0310534
0310535
0310536
0310537
0310538
0310539
0310540
0310541
0310542
0310543
0310317
0310321
0310322
0300730
Product: Solea Model 2.0 Laser Surgical Instrument
Model / REF:
Solea Model 2.0
Foot Pedal assembly SUB-00434
Foot pedal CUS-00226 Rev. K
UPC Codes:
00850634007001
Lot Numbers:
0200822
0200807
0200810
0200625
CDS2-U33W-1B-DE-15
0200819
0200401

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93203
Status: Active
Manufacturer: Convergent Dental
Sold By: Convergent Dental authorized distributors
Manufactured In: United States
Units Affected: 39 units
Distributed To: Alaska, Alabama, California, Connecticut, Florida, Kentucky, Maine, Michigan, Missouri, Montana, North Carolina, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.