Olympus recalls 64 models of HF resection electrodes due to risk of loop wire breaking when contacting metal, potentially causing fragments to fall into patients and uncontrolled heating.
Additional Caution statements in IFU: (1) Due to complaints where the loop wire at the distal end of the HF resection electrode broke after getting in contact with metal objects, such as other endoscopic equipment, implants or stents. As a result, fragments can fall inside the patient and must be retrieved. (2) The second Caution refers to the risk of sparkover when getting in contact with metal parts as this can cause uncontrolled heating of the HF-resection electrode and may result in damage and breakage to the HF-resection electrode tip
Olympus is recalling 64 models of HF resection electrodes used in endoscopic procedures. The electrodes can break when contacting metal objects, causing fragments to fall into patients and potentially causing uncontrolled heating.
The loop wire at the distal end of the electrode can break when contacting metal objects like other endoscopic equipment, implants, or stents. This may cause fragments to fall into the patient and require retrieval. Additionally, contact with metal parts can cause sparkover, leading to uncontrolled heating and potential damage to the electrode tip.
Patients undergoing urological or gynecological procedures using these electrodes are most at risk. The affected products are used by medical professionals in hospitals and clinics.
Check the product model numbers listed in the recall notice (64 specific models) or the unique identification numbers (UDIs) provided. These are typically found on the product packaging or label.
Identify the model number on the product label or packaging to confirm if it is one of the 64 recalled models.
Reach out to Olympus Corporation of the Americas for further assistance or to confirm if your product is affected.
The recall is due to complaints that the loop wire at the distal end of the electrode can break when contacting metal objects, potentially causing fragments to fall into patients and uncontrolled heating.
The recall includes 64 specific model numbers, such as A22201C, A22201D, A22202C, and WA22301D.
Check the product model number on the label or packaging against the list of 64 recalled models provided in the recall notice.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-2413-2023 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-2413-2023 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.
