The Everest Bipolar Cutting Forceps are intended to be passed through… — Class II medical device recall Z-2542-2024
Ongoing recall by Olympus Corporation of the Americas, reported 2024-08-14, distributed nationwide. Fractures and breakages in packaging trays and Tyvek covers, which may result in a sterility breach
| Recall number | Z-2542-2024 |
|---|---|
| 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 | 2024-07-01 |
| Classified | 2024-08-08 |
| Reported by FDA | 2024-08-14 |
| Distributed | Nationwide (US) |
| Quantity | 4,364 units |
| Reason classes | sterility, device malfunction |
| UPC / GTIN / UDI-DI | 00821925035898 |
| Lot numbers | FR145210, FR150478, FR163740, FR165213, FR177466, FR179534, FR179557, FR188129, FR200177, FR215047, FR220528, FR220979, FR224466, FR234887, FR248322, FR253501, FR255664, FR263141, FR269277, FR276180, FR287091, FR303624, FR305537, FR316877, FR378738, FR388883, PW308633, PW308686, PW308722, PW308723 |
| Model numbers | 3000, 3005, 3006 |
Product
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 energy under visualization. The device is to be used with bipolar outputs of compatible generators. The forceps' jaws are electrically isolated from each other enabling one jaw to act as a return electrode, eliminating the need for a return pad. To transect tissue, a cutting blade is actuated and moves between the electrode jaws. The connections (bipolar electrical signal) to the forceps are through either a hardwired cable (model 3006) or a connector at the bottom of the handle (models 3000 and 3005). The device includes mechanisms (switches and triggers) to provide coagulation using the bipolar electrical energy that reaches the forceps. The forceps are positioned in the desired location for grasping, coagulation, and transection of tissue. The anatomical structure to be coagulated is placed between the open forceps jaws, and once the Forceps Grip trigger is squeezed, the forceps' jaws are closed onto tissue, followed by coagulation. The device includes a blade that is mechanically advanced to perform tissue cutting as needed.
Reason for recall
Fractures and breakages in packaging trays and Tyvek covers, which may result in a sterility breach
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-2542-2024. 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.