FDA Device recall Z-0718-2024
SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS
- FDA Device
- Class II
- ongoing
- Published 2024-01-24
On 2024-01-24 the FDA classified a Class II recall of SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS by Olympus, citing affected products may potentially have a breached sterile pouch seal. A breached sterile pouch seal may lead to minor procedure delays (if noticed prior to use) or patient infecti….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0718-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-12-04 |
| Published | 2024-01-24 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Olympus |
| Distribution | AK, AR, AZ, CA, FL, GA, IA, ID, IN, KS, KY, LA, MA, MI, NC, ND, NE, NJ, NY, OR, PA, SC, SD, TN, TX, VA, WI |
Product
SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS
Reason
Affected products may potentially have a breached sterile pouch seal. A breached sterile pouch seal may lead to minor procedure delays (if noticed prior to use) or patient infections (if not noticed prior to use in patient).
Identifiers
| code_info | UDI-DI 00821925043985 Lot KR262848 |
|---|
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-0718-2024%22
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