Everest Bipolar Cutting Forceps (Olympus) – Packaging Breach (2024)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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 an
Brand
Olympus Corporation of the Americas
Lot Codes / Batch Numbers
UDI: N/A Batch Numbers: FR150448 FR154445 FR173022
Products Sold
UDI: N/A Batch Numbers: FR150448 FR154445 FR173022
Olympus Corporation of the Americas is recalling The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depen due to Fractures and breakages in packaging trays and Tyvek covers, which may result in a sterility breach. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Fractures and breakages in packaging trays and Tyvek covers, which may result in a sterility breach
Recommended Action
Per FDA guidance
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 Cynthia.Ow@Olympus.com
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026