Olympus Corporation of the Americas recalled the Thunderbeat, 5 mm, 45 cm, Pistol Grip device on October 22, 2025. The recall affects 30 units distributed worldwide, including the U.S., Canada, Brazil, Germany, Mexico, and Japan. Patients and healthcare providers must stop using this device immediately due to reports of adverse events.
Firm is initiating a removal due to continued reports of adverse events.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Olympus Corporation of the Americas or your healthcare provider for instructions. Notification method: Letter
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
The Olympus Thunderbeat is a surgical device used for various medical procedures. Healthcare providers purchase this device for its advanced features and efficiency during surgery.
The defect in the device has led to adverse events that may compromise patient safety during surgical procedures. Immediate cessation of use is necessary to mitigate risks.
This recall is not part of a broader industry pattern.
Patients and healthcare providers must act quickly to prevent potential adverse effects from continued use of this device.
The model number and UDI can usually be found on the product packaging or the device itself.
Expect a refund processing time of 4-6 weeks after returning the device.
Keep a record of your purchase receipt, all correspondence with Olympus, and any return shipping information.
The recalled product is the Olympus Thunderbeat, 5 mm, 45 cm, Pistol Grip, Model No. TB-0545PC, with UDI: 04953170308635. The recall includes all lots of this model. The product was distributed worldwide, including the United States.
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet instant alerts for recalls that affect you. Free forever.
Olympus recalls 408 SOLTIVE Premium Laser System units worldwide after a defect in the 24V power supply may render the system inoperable and cause smoke or a burning smell. The issue is contained within the internal console and would self-extinguish. Hospitals should stop using the device immediately and follow recall instructions.
Olympus Corporation of the Americas recalled 164 Everest Bipolar Cutting Forceps worldwide on Feb. 25, 2026. A supplier welding process was not adequately validated, risking jaw breakage during surgical use. Clinicians should stop using the device and follow Olympus recall instructions.
Olympus Corporation of the Americas recalled 93 PKS Cutting Forceps worldwide due to welding defects that can cause the jaw to break during clinical use. The issue involves Model 3005PK and UDI 00821925036000. Action is required immediately and providers should follow recall instructions.
Olympus Corporation of the Americas is recalling 106 Everest Bipolar Cutting Forceps worldwide. The devices can have welding defects that may cause the jaw to break during use. Stop using immediately and contact Olympus or your healthcare provider for instructions.
Olympus Corporation of the Americas recalled 326 PKS Cutting Forceps worldwide. The devices may have welding defects that cause the jaw to break during use. Stop using the device immediately and follow the recall instructions provided by Olympus.
Olympus Corporation of the Americas is recalling 2,648 HALO PKS Cutting Forceps HACF0533 sold to hospitals and clinics worldwide. The jaw can break during surgical use due to a supplier welding-validation issue. Healthcare facilities should stop using the device immediately and follow Olympus recall instructions for disposition.
Olympus recalls 7 PKS Cutting Forceps worldwide because welded components may fail. The devices are used with a 5mm cannula and an electrosurgical generator. Stop using the device and follow the manufacturer’s recall instructions. Healthcare facilities should verify device details and consult Olympus for replacement options.
Olympus Corporation of the Americas is recalling 444 PK-CF0533 cutting forceps distributed worldwide. The devices may have welding defects that can cause the jaw to break during surgery. Stop using the device and follow recall instructions from Olympus or your healthcare provider.