Drug recall
Soltive SuperPulsed Laser System TFL FIBER CLEAVER, Model Number TFL-AFC
FDA recall event 93613 · Class II · Olympus Corporation of the Americas
Key facts
| Event ID | 93613 |
|---|---|
| Recall numbers | Z-0716-2024, Z-0717-2024 |
| Recalling firm | Olympus Corporation of the Americas |
| Product type | Devices |
| Products | Soltive SuperPulsed Laser System TFL FIBER CLEAVER, Model Number TFL-AFC, Soltive SuperPulsed Laser System TFL Fiber Stripper, Model Numbers TFL-AFS150, TFL-AFS200, TFL-AFS365, TFL-AFS550, TFL-AFS940 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Dec 4, 2023 |
| Report date | Jan 24, 2024 |
| City | Center Valley |
| State | PA |
| Country | United States |
| FEI number | 2429304 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: