SOLTIVE SuperPulsed Laser Fibers — Class II medical device recall Z-0718-2024
Ongoing recall by Olympus Corporation of the Americas, reported 2024-01-24, distributed in AK, AR, AZ, CA, FL, GA, IA, ID…. Affected products may potentially have a breached sterile pouch seal. A breached sterile pouch seal may lead t
| Recall number | Z-0718-2024 |
|---|---|
| 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 | 2023-12-04 |
| Classified | 2024-01-12 |
| Reported by FDA | 2024-01-24 |
| Distributed | 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 |
| Countries outside the US | CA |
| Quantity | 179 units |
| Reason classes | sterility, packaging |
| UPC / GTIN / UDI-DI | 00821925043985 |
| Lot numbers | KR262848 |
| Model numbers | TFL-FBX200BS |
Product
SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS
Reason for recall
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).
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-0718-2024. 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.