Solea Models 2 — Class II medical device recall Z-0324-2024
Ongoing recall by Convergent Dental, reported 2023-11-29, distributed nationwide. It has been found that potential unintended laser activation can occur without foot pedal depression.
| Recall number | Z-0324-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Convergent Dental, Needham, MA, United States |
| Recall initiated | 2023-09-01 |
| Classified | 2023-11-17 |
| Reported by FDA | 2023-11-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 39 units |
| UPC / GTIN / UDI-DI | 00850634007001, 00850634007018 |
| Serial numbers | 0200401, 0200625, 0200807, 0200810, 0200819, 0200822, 0300730, 0310317, 0310321, 0310322, 0310516, 0310517, 0310518, 0310519, 0310520, 0310521, 0310522, 0310523, 0310524, 0310525, 0310526, 0310527, 0310528, 0310529, 0310530 and 14 more |
| Model numbers | 2.0, 3.0 |
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 for recall
It has been found that potential unintended laser activation can occur without foot pedal depression.
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-0324-2024. 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.