Use cautionMedical device recall · FDA · Published March 1, 2024
Olympus Triangle Tip Electrosurgical Knives Recall: Risk of Serious Injury from Breaking
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
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Contact the company
📍Recalling firmOlympus Corporation of the Americas3500 Corporate Pkwy · Center Valley, PA 18034-8229
“Olympus Triangle Tip Electrosurgical Knives Recall: Risk of Serious Injury from Breaking.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/56020-olympus-triangle-tip-electrosurgical-knives-recall-risk-of-serious-injury. Based on FDA recall #Z-1548-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1548-2024%22&limit=1).
The FDA announced on March 1, 2024, that Olympus Corporation of the Americas is recalling KD-645L Triangle Tip Electrosurgical Knives due to reports of the devices breaking off during use. This hazard has led to serious injuries. The agency issued recall number Z-1548-2024.
How to tell if you have it
Brand: Olympus
Model: KD-645L
UDI-DI: 04953170407857
Lots: All lots numbers
The hazard
The recall addresses complaints regarding the KD-640L and KD-645L Triangle Tip Electrosurgical Knives breaking off during use. The FDA issued this 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.
Context
GovInfoNow's records show Olympus Corporation of the Americas has 133 other recalls on record since August 18, 2017. Other recent recalls include the Olympus Tripp-Lite P580-025 DisplayPort Cable recall (August 27, 2026), the Olympus M3 Gold Autoclavable Lateral Telescope 70 recall (August 24, 2026), and the Olympus BiCOAG Hemostasis Probe 7Fr Coaxial Connector recall (August 19, 2026). Similar product recalls include the Olympus OER-Pro Recall (October 31, 2025), the Wilson-Cook Instinct Plus Endoscopic Clipping Device Recall (March 3, 2026), and the B. Braun 21GA Winged Infusion Needle Recall (February 2, 2026).
How to tell if you have this one
Check for the model number KD-645L on the knife. The product was sold with specific lot numbers and UDI-DI: 04953170407857.
Brand
Olympus
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
Nationwide
Recall number
Product, codes & lots
Quantity
Z-1547-2024
Olympus Triangle Tip Electrosurgical Knives- to be used with Olympus endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract Model: KD-640L; UDI-DI: 04953170208423 All lots numbers
4507 units
Z-1548-2024
Olympus Triangle Tip Electrosurgical Knives- to be used with Olympus endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract Model: KD-645L; UDI-DI: - 04953170407857 All lots numbers
2525 units
Based on the official FDA remedy
What to do — step by step
Check Compatibility
Ensure the electrosurgical knife is used with a compatible electrosurgical unit as per the Instructions for Use.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 7 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-1548-2024 (March 1, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1548-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.