PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: September 18, 2024 Initiated: March 1, 2024 #Z-1548-2024

Product Description

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

Reason for Recall

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

Details

Units Affected
2525 units
Distribution
Nationwide
Location
Center Valley, PA

Frequently Asked Questions

What product was recalled?
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. Recalled by Olympus Corporation of the Americas. Units affected: 2525 units.
Why was this product recalled?
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
Which agency issued this recall?
This recall was issued by the FDA Devices on September 18, 2024. Severity: Moderate. Recall number: Z-1548-2024.