Official recall record

Olympus Triangle Tip Electrosurgical Knives- to be used with Olympus endoscopes and electrosurgical units to cut tissue using high-frequency

US FDA — Medical Devices · 2024-03-01 · United StatesClass II

Issuing authority: US FDA — Medical Devices
Alert date: 2024-03-01
Country of alert: United States
Alert level: Class II
Alert type: recall
Barcode (EAN/GTIN): 04953170407857
Brand on record: Olympus Corporation of the Americas

What the authority reported

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

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

More recalls: US FDA — Medical Devices · United States · all filters

Same barcode in other registries

The same EAN appears in 1 other official recall record(s) — a cross-border signal worth checking if you bought this product abroad.

2024-02-17 · US FDA — Medical Devices
Brand Name: Single Use Electrosurgical Knife KD-645 Product Name: Olympus Single Use Electrosurgical Knife KD-645 Mode

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