Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE… — Class II medical device recall Z-1715-2025
Ongoing recall by Olympus Corporation of the Americas, reported 2025-05-07, distributed nationwide. Preset treatment parameters are not consistently being used in accordance with the IFU.
| Recall number | Z-1715-2025 |
|---|---|
| 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 | 2025-04-04 |
| Classified | 2025-05-01 |
| Reported by FDA | 2025-05-07 |
| Distributed | Nationwide (US) |
| Quantity | 189 |
| UPC / GTIN / UDI-DI | 00821925044111, 00821925044135, 00821925044586, 00821925044593 |
Product
Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System Model/Catalog Numbers: TFL-SLS, TFL-PLS Product Description: SOLTIVE Laser Systems use technology to increase procedural efficiency and flexibility to ureteroscopy, PCNL, and potential soft tissue applications. Component: No
Reason for recall
Preset treatment parameters are not consistently being used in accordance with the IFU.
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-1715-2025. 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.