Soltive Premium Super Pulsed Laser System — Class II medical device recall Z-2294-2021
Terminated recall by Olympus Corporation of the Americas, reported 2021-08-25, distributed nationwide. Thermal injury following dusting and fragmenting treatment of ureteral stones when user exceeded the 20W stand
| Recall number | Z-2294-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Olympus Corporation of the Americas, Center Valley, PA, United States |
| Recall initiated | 2021-06-30 |
| Classified | 2021-08-15 |
| Reported by FDA | 2021-08-25 |
| Terminated | 2024-01-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, HK, JP, SG |
| Quantity | 408 units |
| Reason classes | foreign material |
Product
Soltive Premium Super Pulsed Laser System (TFL-PLS) & Pro Super Pulsed Laser System (TFL-SLS). Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in urology, lithotripsy, gastroenterological surgery and gynecological surgery
Reason for recall
Thermal injury following dusting and fragmenting treatment of ureteral stones when user exceeded the 20W standard presets
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-2294-2021. 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.