Soltive Pro SuperPulsed Laser System — Class II medical device recall Z-2505-2024
Ongoing recall by Olympus Corporation of the Americas, reported 2024-08-14, distributed nationwide. Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the surgical proc
| Recall number | Z-2505-2024 |
|---|---|
| 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 | 2024-05-31 |
| Classified | 2024-08-05 |
| Reported by FDA | 2024-08-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, CL, DE, HK, JP, SG |
| Quantity | 253 units |
| UPC / GTIN / UDI-DI | 00821925044135 |
Product
Soltive Pro SuperPulsed Laser System, Model TFL-SLS
Reason for recall
Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the surgical procedure.
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-2505-2024. 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.