Olympus Recalls Thunderbeat Surgical Devices Due to Adverse Event Reports

What Happened

Olympus Corporation of the Americas has initiated a voluntary recall of specific Thunderbeat surgical devices. The firm is removing the products from the market due to continued reports of adverse events. The FDA has classified this as a Class II recall, following the firm’s initial notification on October 22, 2025.

Which Products Are Affected

The recall affects all units of the following product:

• Product Name: Olympus Thunderbeat 5 mm, 10 cm, Inline Grip
• Model Number: TB-0510IC
• UDI: 04953170308734
• Quantity: 1,538 units

These devices were distributed worldwide, including across the United States and in Brazil, Canada, Germany, Mexico, and Japan.

What You Should Do

Olympus Corporation of the Americas initiated the recall process by sending notification letters to affected customers. Healthcare facilities and providers should check their inventory for Model No. TB-0510IC. For further instructions regarding the removal or return of these units, contact Olympus at their headquarters: 3500 Corporate Pkwy, Center Valley, PA 18034.

Why This Matters

This recall is significant because it involves specialized surgical equipment. The reports of adverse events indicate that the device may pose a safety risk to patients during medical procedures.

Source

Recall information and data provided by the FDA. Recall Number: Z-1382-2026.