Drug recall
The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on…
FDA recall event 94953 · Class II · Olympus Corporation of the Americas
Key facts
| Event ID | 94953 |
|---|---|
| Recall numbers | Z-2540-2024, Z-2541-2024, Z-2542-2024 |
| Recalling firm | Olympus Corporation of the Americas |
| Product type | Devices |
| Products | The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on the model/outer diameter size of the forceps. Coagulation is achieved using electrosurgical… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Fractures and breakages in packaging trays and Tyvek covers, which may result in a sterility breach |
| Initiation date | Jul 1, 2024 |
| Report date | Aug 14, 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: