Olympus Everest Bipolar Cutting Forceps Recall: Packaging Fractures Risk Sterility Breach
Olympus recalls Everest Bipolar Cutting Forceps with packaging that may fracture, risking sterility breaches during surgery. Affected units have specific batch numbers. Contact Olympus for details.
Lower-risk recall
Fractures and breakages in packaging trays and Tyvek covers, which may result in a sterility breach
Contact the company
What happened, in plain English
Olympus is recalling Everest Bipolar Cutting Forceps due to packaging that can fracture, potentially causing sterility breaches during surgical procedures. This recall affects specific batch numbers of the devices. Read more at govinfonow.com/recall/54708-olympus-everest-bipolar-cutting-forceps-recall-packaging-fractures-risk-sterility.
Source Summary by GovInfoNow · govinfonow.com/recall/54708-olympus-everest-bipolar-cutting-forceps-recall-packaging-fractures-risk-sterility · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2540-2024
Cite this page
“Olympus Everest Bipolar Cutting Forceps Recall: Packaging Fractures Risk Sterility Breach.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54708-olympus-everest-bipolar-cutting-forceps-recall-packaging-fractures-risk-sterility. Based on FDA recall #Z-2540-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2540-2024%22&limit=1).
Why it’s dangerous
The packaging trays and Tyvek covers for these surgical tools can fracture, which may lead to a sterility breach during procedures. This could happen if the packaging is damaged or compromised before use, potentially introducing contaminants into the surgical field.
Who’s affected
Surgical professionals using Olympus Everest Bipolar Cutting Forceps with batch numbers FR150448, FR154445, or FR173022 are most at risk. These devices are used in surgical settings for tissue cutting and coagulation.
How to tell if you have this one
Check for batch numbers FR150448, FR154445, or FR173022 on the packaging. The Everest Bipolar Cutting Forceps are used in surgical settings for tissue cutting and coagulation.
- Brand
Olympus- Category
Medical device
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
Worldwide distribution - US Nationwide and the countries of CA, DE, AU, SG, KR.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-2540-2024 | 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.; UDI: N/A Batch Numbers: FR150448 FR154445 FR173022 | 100 unirs |
| Z-2541-2024 | 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.; 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 | 6985 units |
| Z-2542-2024 | 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.; UDI: 00821925035898 Batch Number: 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 | 4364 units |
What to do — step by step
Check Batch Numbers
Look for batch numbers FR150448, FR154445, or FR173022 on the packaging to determine if your device is affected.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide distribution - US Nationwide and the countries of CA, DE, AU, SG, KR.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 44 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
Do I need to stop using these forceps?
No, the recall does not require stopping use; the hazard is low risk and only affects packaging integrity.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2540-2024 (July 1, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2540-2024 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.