Recall archive / FDA device enforcement
Solea Models 2.0 and 3.0 Laser Surgical Instrument, Foot Pedal assembly SUB-00434 with foot pedal CUS-00226 Rev. K re... — FDA record Z-0324-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Sep 1, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Solea Models 2.0 and 3.0 Laser Surgical Instrument, Foot Pedal assembly SUB-00434 with foot pedal CUS-00226 Rev. K reworked
- Reason
- It has been found that potential unintended laser activation can occur without foot pedal depression.
- Classification
- Class II
- Recalling firm
- Convergent Dental
- Quantity
- 39 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0324-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Solea Model 3.0: UDI-DI: 00850634007018; 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, 0300730; Solea Model 2.0: UDI-DI: 00850634007001; Serial Numbers: 0200822, 0200807, 0200810, 0200625, CDS2-U33W-1B-DE-15, 0200819, 0200401 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide - US Nationwide distribution in the states of AK, AL, CA, CT, FL, KY, ME, MI, MO, MT, NC, OH, OR, PA, TN, TX, UT, VA, WA, WI and the country of Canada.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Nov 29, 2023
- Recall initiation date
- Sep 1, 2023
- Center classification date
- Nov 17, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.