Olympus Recalls Thunderbeat Surgical Devices Following Reports of Adverse Events

What Happened

Olympus Corporation of the Americas has initiated a voluntary removal of specific Thunderbeat surgical instruments. The recall was prompted by continued reports of adverse events associated with the use of these devices. The FDA has classified this action as a Class II recall, which was officially classified on February 17, 2026.

Which Products Are Affected

The recall affects the following medical device:

• Product Name: Olympus Thunderbeat 5 mm, 45 cm, Front-Actuated Grip Type S
• Model Number: TB-0545FCS
• UDIs: 04953170383533, 04953170383526, 04953170409684, 04953170383519
• Affected Lots: All lots are included in this recall.
• Quantity: 9,542 units.
• Distribution: The products were distributed nationwide across the United States and internationally to Brazil, Canada, Germany, Mexico, and Japan.

What You Should Do

Olympus began notifying customers of the recall via letter on October 22, 2025. Healthcare facilities, surgeons, and distributors should immediately identify and isolate any remaining inventory of the affected model (TB-0545FCS). For instructions regarding the return or handling of these devices, contact Olympus Corporation of the Americas at their headquarters: 3500 Corporate Pkwy, Center Valley, PA 18034-8229.

Why This Matters

This recall is significant because it involves specialized surgical equipment. The reports of adverse events indicate a potential risk to patient safety during procedures where these devices are utilized.

Source

Information provided by the FDA under Recall Number: Z-1371-2026.