FDA Device recall Z-0717-2024
Soltive SuperPulsed Laser System TFL FIBER CLEAVER, Model Number TFL-AFC
- FDA Device
- Class II
- ongoing
- Published 2024-01-24
On 2024-01-24 the FDA classified a Class II recall of Soltive SuperPulsed Laser System TFL FIBER CLEAVER, Model Number TFL-AFC by Olympus, citing the strippers and cleavers are provided non-sterile and labelled as reusable/autoclavable. Olympus does not have validated cleaning and sterilization instructions. Use of a non-st….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0717-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-12-04 |
| Published | 2024-01-24 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Olympus |
| Distribution | US |
Product
Soltive SuperPulsed Laser System TFL FIBER CLEAVER, Model Number TFL-AFC
Reason
The strippers and cleavers are provided non-sterile and labelled as reusable/autoclavable. Olympus does not have validated cleaning and sterilization instructions. Use of a non-sterile fiber stripper or cleaver on a sterile fiber poses a risk of contamination.
Identifiers
| code_info | Lot Number: All units sold prior to 2023 |
|---|
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-0717-2024%22
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