Olympus recalls KD-645L Triangle Tip Electrosurgical Knives due to reports of serious injury from knives breaking off during use. Affected units were sold with specific model and lot numbers.
Due to increase in complaints for the KD-640L and KD-645L Triangle Tip Electrosurgical Knives breaking off during use -issuing reminder to users to utilize the electrosurgical knife in accordance with the Instructions for Use, which details critical specifications regarding electrosurgical unit compatibility and output due to reports of serious injury
Olymp: Olympus is recalling its KD-645L Triangle Tip Electrosurgical Knives because they have broken off during use, causing serious injury. This happens when the knives are used with certain electrosurgical units without proper compatibility.
The knives can break off during use, especially if not used with compatible electrosurgical units. This breakage can cause serious injury, including internal damage or bleeding.
Users of Olympus endoscopes and electrosurgical units who have the KD-645L model knives are affected. Medical professionals performing procedures in the upper digestive tract are most at risk.
Check for the model number KD-645L on the knife. The product was sold with specific lot numbers and UDI-DI: 04953170407857.
Ensure the electrosurgical knife is used with a compatible electrosurgical unit as per the Instructions for Use.
The recall is due to reports of serious injury from the knives breaking off during use.
The affected model is the KD-645L Triangle Tip Electrosurgical Knives.
Look for the model number KD-645L and the specific lot numbers mentioned 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-1548-2024 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1548-2024 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.
