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The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, de...

FDA Device Recall #Z-2541-2024 — Class II — July 1, 2024

Recall Summary

Recall Number Z-2541-2024
Classification Class II — Moderate risk
Date Initiated July 1, 2024
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Olympus Corporation of the Americas
Location Center Valley, PA
Product Type Devices
Quantity 6985 units

Product Description

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

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of CA, DE, AU, SG, KR.

Lot / Code Information

UDI: 00821925035881 Batch Number: FR137723 FR139935 FR141534 FR145203 FR157420 FR165250 FR176934 FR179541 FR197926 FR204443 FR206007 FR207123 FR214689 FR215012 FR215026 FR246906 FR261731 FR297010 FR305512 FR308131 FR335638 FR335650 FR378737 FR390629 FR397748 PW308683

Other Recalls from Olympus Corporation of the Americas

Recall # Classification Product Date
Z-1641-2026 Class II Brand Name: Olympus HALO PKS Cutting Forceps, 5... Feb 25, 2026
Z-1640-2026 Class II Brand Name: Olympus PK Cutting Forceps, 5mm 33c... Feb 25, 2026
Z-1642-2026 Class II Brand Name: Olympus PKS Cutting Forceps, 5mm 33... Feb 25, 2026
Z-1639-2026 Class II Brand Name: Olympus Everest Bipolar Cutting For... Feb 25, 2026
Z-1643-2026 Class II Brand Name: Olympus PKS Cutting Forceps w/Cord,... Feb 25, 2026

Frequently Asked Questions

Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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