Soltive SuperPulsed Laser System TFL Fiber Stripper — Class II medical device recall Z-0716-2024
Ongoing recall by Olympus Corporation of the Americas, reported 2024-01-24, distributed nationwide. The strippers and cleavers are provided non-sterile and labelled as reusable/autoclavable. Olympus does not ha
| Recall number | Z-0716-2024 |
|---|---|
| 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 | Nationwide (US) |
| Quantity | 3,001 units |
| Reason classes | sterility |
| Model numbers | TFL-AFS150, TFL-AFS200, TFL-AFS365, TFL-AFS550, TFL-AFS940 |
Product
Soltive SuperPulsed Laser System TFL Fiber Stripper, Model Numbers TFL-AFS150, TFL-AFS200, TFL-AFS365, TFL-AFS550, TFL-AFS940
Reason for recall
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.
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-0716-2024. 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.