Olympus recalls ESG PK Cutting Forceps (5mm, 33cm) due to risk of jaw fracture during inspection or procedures. Affected units have specific lot numbers and model codes.
The jaw may fracture prior to the procedure during the inspection instructed per the IFU, or during the procedure.
Olympus is recalling ESG PK Cutting Forceps (5mm, 33cm) because the jaw may fracture during inspection or procedures as instructed in the user manual. This could lead to injury if the forceps break unexpectedly while in use.
The forceps' jaw can fracture during the inspection steps or procedures as outlined in the user manual. This fracture risk occurs while the device is being used, potentially causing injury to the user or patient.
Medical professionals using these forceps for procedures are most at risk. Patients using the forceps during medical inspections or procedures may also be affected.
Check for model PK-CF0533 and lot numbers listed in the recall (e.g., FR258486, FR261738). The product is sold under Olympus Corporation of the Americas.
Identify the model number (PK-CF0533) and lot numbers from the recall list to confirm if your forceps are affected.
Reach out to Olympus Corporation of the Americas for further assistance or to confirm if your specific model is recalled.
The recall is due to the risk of the forceps' jaw fracturing during inspection or procedures as instructed in the user manual.
Check the model number and lot numbers listed in the recall to see if your forceps are affected. Contact Olympus for further assistance.
Yes, the fracture could cause injury during use, especially during procedures or inspections as per the user manual.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1167-2024 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1167-2024 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.
