Olympus Recalls Single Use Electrosurgical Knife KD-645 Over Tip Breakage Concerns

What Happened

Olympus Corporation of the Americas has initiated a voluntary recall of the Single Use Electrosurgical Knife KD-645. The recall was prompted by reports of deterioration of the cutting knife, including instances of overheating and burning. These conditions can contribute to the tip of the device breaking while in use during surgical procedures.

Which Products Are Affected

The recall involves 3,361 units of the following medical device:

• Brand Name: Single Use Electrosurgical Knife KD-645
• Model/Catalog Number: KD-645L
• UDI: 04953170407857
• Lot Numbers: 2ZK, 31K, 32K, 33K, 35K, 3XK, 3YK, 3ZK, 42K, 43K, 44K, 45K, 46K, 47K, 48K, 49K, 4XK, 4YK, 4ZK, 51K, 52K, 53K, 54K, 55K, 56K, 57K, 58K, 59K

These devices are intended for use in endoscopic surgeries (including laparoscopic and arthroscopic) to deliver current for tissue cutting, coagulation, or ablation.

What You Should Do

The firm initiated the recall through a notification letter sent to affected customers. Healthcare providers and facilities should immediately check their inventory for the specified lot numbers. Affected units should be quarantined and handled according to the instructions provided by Olympus. For additional information regarding the return process, 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. Tip breakage during surgery poses a serious risk, as it may require additional procedures to retrieve the broken component or cause unintended tissue damage.

Source

Recall information provided by the FDA under Recall Number Z-1223-2026.