FDA-Device2026-02-11Class IIPROCESSING DEFECT
Olympus Single Use Electrosurgical Knife KD-645L recalled for tip breakage risk
Stop using Olympus electrosurgical knife KD-645L
Olympus is recalling its Single Use Electrosurgical Knife model KD-645L because the cutting tip can overheat, deteriorate, and break during surgery. This may occur in certain lot numbers manufactured between specific production runs. No injuries have been reported.
- Check if you have the affected model KD-645L with lot numbers 2ZK through 59K (check your device packaging)
- Stop using affected units immediately
- Contact Olympus Corporation of the Americas with your lot number for replacement or return instructions
- Notify your surgical facility's medical device coordinator or compliance officer
Hazard
A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.
Sold states
US Nationwide distribution.
Affected count
3361 units
Manufactured in
3500 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
Brand Name: Single Use Electrosurgical Knife KD-645 Product Name: Olympus Single Use Electrosurgical Knife KD-645 Model/Catalog Number: KD-645L Product Description: An electrosurgical device consisting of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver a current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1223-2026More Olympus Corporation of the Americas recalls
- FDA-Device2026-04-08Olympus SOLTIVE Premium laser system recalled for defective power supply
- FDA-Device2026-04-08Olympus SOLTIVE Pro SuperPulsed Laser System recalled for power supply defect
- FDA-Device2026-04-01Olympus PKS Cutting Forceps recalled for defective welds causing jaw breakage
- FDA-Device2026-04-01Olympus MAJ-1443 and MAJ-1444 endoscope suction valves no longer compatible with OER-Pro and OER-Elite reprocessors
- FDA-Device2026-04-01Olympus PKS Cutting Forceps recalled for defective welds causing jaw breakage
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