Class II — Convergent Dental
| Recalling firm | Convergent Dental |
|---|---|
| Registered facility | CONVERGENT DENTAL (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | It has been found that potential unintended laser activation can occur without foot pedal depression. |
| Product | 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 |
| 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. |
| Initiated | 2023-09-01 |
| Classified | 2023-11-17 |
| Recall number | Z-0324-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Convergent Dental (Z-0324-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/93203/
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