FDA Device recall Z-2505-2024
Soltive Pro SuperPulsed Laser System, Model TFL-SLS
- FDA Device
- Class II
- ongoing
- Published 2024-08-14
On 2024-08-14 the FDA classified a Class II recall of Soltive Pro SuperPulsed Laser System, Model TFL-SLS by Olympus, citing difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the surgical procedure.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2505-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-05-31 |
| Published | 2024-08-14 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Olympus |
| Distribution | US |
Product
Soltive Pro SuperPulsed Laser System, Model TFL-SLS
Reason
Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the surgical procedure.
Identifiers
| code_info | Model: TFL-SLS; UDI-DI: 00821925044135; Serial Numbers: All Serial Numbers. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2505-2024%22
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