Olympus recalls Everest Bipolar Cutting Forceps due to packaging tray and Tyvek cover fractures that could cause sterility breaches during surgery. Affected units have specific batch numbers and model numbers.
Fractures and breakages in packaging trays and Tyvek covers, which may result in a sterility breach
Olympus is recalling Everest Bipolar Cutting Forceps because packaging trays and Tyvek covers can fracture, potentially causing a sterility breach during surgical procedures. This risk is serious for surgical teams using the devices.
The packaging trays and Tyvek covers for the forceps can fracture during handling or storage. If these components break, they may compromise the sterility of the surgical instruments, leading to potential infections or contamination during procedures.
Surgical teams and medical professionals who use the Everest Bipolar Cutting Forceps for procedures. Those with the specific batch numbers listed in the recall are most at risk.
Check for the batch numbers listed in the recall: 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. The devices are used in surgical settings and come with specific model numbers.
Verify if your Everest Bipolar Cutting Forceps have any of the listed batch numbers: 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.
The packaging trays and Tyvek covers for the Everest Bipolar Cutting Forceps can fracture, which may result in a sterility breach during surgical procedures.
The affected batch numbers are 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.
No, the recall does not require immediate discontinuation. However, if your forceps have the listed batch numbers, you should check the packaging for fractures and ensure sterility is maintained.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-2541-2024 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-2541-2024 from Olympus. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.