Olympus Corporation Recalls Thunderbeat Surgical Devices Due to Adverse Event Reports

What Happened

Olympus Corporation of the Americas has initiated a voluntary recall for its Thunderbeat surgical instruments. The firm is removing the products from the market following continued reports of adverse events related to the device’s use. The FDA has classified this as a Class II recall, which was officially classified on February 17, 2026.

Which Products Are Affected

The recall involves the following medical device:

• Product Name: Olympus Thunderbeat, 5mm, 35 cm, Pistol Grip
• Model Number: TB-0535PC
• UDI: 04953170308659
• Affected Lots: All lots are included in this recall.
• Quantity: 3,381 units.
• Distribution: The product was distributed worldwide, including throughout the United States, Brazil, Canada, Germany, Mexico, and Japan.

What You Should Do

Olympus Corporation of the Americas notified customers of the removal via a formal letter initiated on October 22, 2025. Healthcare providers and facilities possessing these devices should follow the specific instructions outlined in the firm’s notification regarding the removal of the affected units. For additional inquiries, the recalling firm is located at 3500 Corporate Pkwy, Center Valley, PA 18034.

Why This Matters

This recall is significant as it involves a surgical device with reported adverse events, posing a potential risk to patient safety during medical procedures.

Source

Information sourced from the U.S. Food and Drug Administration (FDA). Recall Number: Z-1378-2026.