Z-2542-2024Class II

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

Name: Z-2542-2024 The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on...
Creator: Olympus Corporation of the Americas
Published: 2024-07-01
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2024-07-01 / Open, Classified / root cause: packaging

FDA source

Olympus Corporation of the Americas began a recall of 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... on 2024-07-01. FDA classified it as Class II and gives the reason as "Fractures and breakages in packaging trays and Tyvek covers, which may result in a sterility breach". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2542-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-07-01
Posted: 2024-08-08
Recalling firm: OLYMPUS Corporation of the Americas
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.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Fractures and breakages in packaging trays and Tyvek covers, which may result in a sterility breach
Root cause tag: packaging
FDA root cause: Package design/selection
Action: Olympus issued Urgent Medical Device Removal letter on July 1, 2024. Letter states reason for recall, health risk and action to take: 1. Carefully read the content of this notification. 2. Examine your inventory and identify the above listed device(s) with the affected batch number. 3. Please contact Customer Service at 1-800-848-9024, option 2, to obtain a Return Material Authorization. Olympus will arrange for the return of your device to Olympus. When it is received, you will receive a credit for your affected device(s). 4. Olympus requests that you acknowledge receipt of this letter. Access the Olympus recall portal to indicate that you have received this notification. a. Go to https://olympusamerica.com/recall b. Enter the recall number "0449 c. Complete the form as instructed and include your account ID number. 5. If you have further distributed this product, identify your customers, and forward them this notification. Olympus requests that you report any complaints, including package damage or signs of sterility breach, to the Technical Assistance Center (TAC) at 1- 800-848-9024, option 1. If you require additional information, please do not hesitate to contact me directly by phone at (647) 999-3203 or by e-mail at [email protected]
Quantity in commerce: 4364 units
Distribution: Worldwide distribution - US Nationwide and the countries of CA, DE, AU, SG, KR.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2542-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2540-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-08-14	2024-08-08
Z-2541-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-08-14	2024-08-08
Z-2542-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-08-14	2024-08-08

Product code GEI

K023492Class IIEverest Bipolar Cutting Forceps and Gyrus Bipolar Cutting ForcepsGyrus Medical, Inc. / cleared 2002-11-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)