Olympus Recalls Single Use Electrosurgical Knife KD-640L Due to Tip Breakage Risk

What Happened

Olympus Corporation of the Americas has initiated a voluntary recall of the Olympus Single Use Electrosurgical Knife KD-640L. The recall was prompted by reports of deterioration of the cutting knife, which can include overheating and burning. These conditions can contribute to the knife tip breaking during medical procedures.

Which Products Are Affected

The recall involves the following medical device:

• Product Name: Olympus Single Use Electrosurgical Knife KD-640L
• Model/Catalog Number: KD640-L
• UDI: 04953170208423
• Lot Numbers: 2ZK, 31K, 32K, 33K, 34K, 35K, 36K, 37K, 38K, 39K, 3XK, 3YK, 3ZK, 41K, 42K, 43K, 44K, 45K, 46K, 47K, 48K, 49K, 4XK, 4YK, 4ZK, 51K, 52K, 53K, 54K, 55K, 58K, 59K

This product is an electrosurgical device intended for cutting, coagulation, and ablation during endoscopic surgeries. The affected units were distributed nationwide across the United States.

What You Should Do

Olympus Corporation of the Americas notified affected customers via letter. Healthcare facilities and providers should immediately check their inventory for the specified model and lot numbers. Affected units should be quarantined to prevent use. For further information regarding returns or technical questions, contact Olympus Corporation of the Americas at 3500 Corporate Pkwy, Center Valley, PA 18034.

Why This Matters

This is a Class II recall, indicating that the use of the defective device may cause temporary or medically reversible adverse health consequences. The primary risk involves the potential for device fragments to break off inside a patient during surgery due to overheating or deterioration.

Source

Information provided by the FDA under Recall Number Z-1222-2026.