Olympus Corporation of the Americas: Medical Device Recall in 2024 - (Recall #: Z-1547-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

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-640L

Product Classification:

Class II

Date Initiated: March 1, 2024

Date Posted: September 18, 2024

Recall Number: Z-1547-2024

Event ID: 94173

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

Status: Ongoing

Product Quantity: 4507 units

Code Information:

UDI-DI: 04953170208423 All lots numbers

Distribution Pattern:

Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated