Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE… — Class II medical device recall Z-1921-2025
Ongoing recall by Olympus Corporation of the Americas, reported 2025-06-18, distributed nationwide. Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flame
| Recall number | Z-1921-2025 |
|---|---|
| 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 | 2025-05-06 |
| Classified | 2025-06-06 |
| Reported by FDA | 2025-06-18 |
| Distributed | Nationwide (US) |
| UPC / GTIN / UDI-DI | 00821925044111 |
Product
Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Premium SuperPulsed Laser System Model/Catalog Number: TFL-PLS, TFL-PLS-JA (Japan only); Software Version: N/A Product Description: SOLTIVE Laser Systems use technology to increase procedural efficiency and flexibility to ureteroscopy, PCNL, and potential soft tissue applications. Component: N/A
Reason for recall
Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. The fracturing of the fiber is the cause of, or contributes to, these thermal incidents.
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-1921-2025. 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.