SOLTIVE Pro SuperPulsed Laser — Class II medical device recall Z-1384-2024
Ongoing recall by Olympus Corporation of the Americas, reported 2024-04-03. A non-compliant power cord may have been supplied in regions that do not utilize the Type B or Type E/F plug c
| Recall number | Z-1384-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Olympus Corporation of the Americas, Center Valley, PA, United States |
| Recall initiated | 2024-01-29 |
| Classified | 2024-03-27 |
| Reported by FDA | 2024-04-03 |
| Countries outside the US | AU, CL, DE, HK, JP, NZ, SG |
| Quantity | 17 units |
| UPC / GTIN / UDI-DI | 00821925044135 |
Product
SOLTIVE Pro SuperPulsed Laser (TFL-SLS )
Reason for recall
A non-compliant power cord may have been supplied in regions that do not utilize the Type B or Type E/F plug configurations.
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-1384-2024. 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.