Olympus Corporation of the Americas recalled 88,268 units of the Thunderbeat surgical device on October 22, 2025. The recall follows reports of adverse events associated with the device. Healthcare providers and patients should stop using the device immediately and follow the recall instructions.
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 recall affects the Olympus Thunderbeat, 5 mm, 35 cm, Front-Actuated Grip Type S. Model numbers include TB-0535FCS, UDI: 04953170383564, 04953170383557, 04953170409677, and 04953170383540. The devices were distributed worldwide, including the US, Brazil, Canada, Germany, Mexico, and Japan.
The recall stems from continued reports of adverse events linked to the device. While specific incidents have not been detailed, the high hazard level indicates a significant risk that could affect patient safety.
The number of reported incidents remains unspecified. However, the classification as a Class II recall suggests serious concerns that could lead to injury.
Patients and healthcare providers should immediately cease using the device. Contact Olympus Corporation of the Americas or your healthcare provider for further instructions. Follow any additional recall guidance provided in the notification letter.
For more information, contact Olympus Corporation of the Americas at 1-800-635-5587 or visit https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1372-2026.
Get instant alerts for recalls that affect you. Free forever.
Taro Pharmaceuticals announced a market withdrawal of Diclofenac Sodium, Topical Gel, 3% on January 27, 2026. The withdrawal stems from out of specification viscosity results. Healthcare providers and consumers should stop using the product immediately.
Fresenius Kabi Compounding recalled 1,057 bags of Acyclovir Sodium Injection on February 5, 2026. The recall stems from a lack of assurance of sterility, posing a high health risk. Healthcare providers should cease use immediately and contact the manufacturer for guidance.
Fresenius Kabi Compounding recalled its vancomycin HCl injection on February 5, 2026, due to a lack of assurance of sterility. This Class II recall affects all lots distributed nationwide. Healthcare providers and consumers must stop using the product immediately.
Fresenius Kabi Compounding recalled 1,578 bags of vancomycin HCl injection on February 5, 2026. The company cited a lack of assurance of sterility as the reason for the recall. Healthcare providers and consumers should stop using the product immediately.
Fresenius Kabi Compounding recalled 1,410 bags of ketamine HCl injection on February 5, 2026. The recall stems from a lack of assurance of sterility, posing a high health risk. Healthcare providers and consumers must stop using this product immediately.
Fresenius Kabi Compounding recalled 10,548 bags of thiamine HCl injection on February 5, 2026. The recall follows a lack of assurance of sterility, posing a high health risk. Affected products include several lots expiring between February and May 2026.
Pro Numb Tattoo Numbing Spray was recalled due to cGMP deviations. The recall affects products distributed nationwide in the USA. Consumers should stop using the spray immediately and contact Pro Numb Tattoo Numbing Spray LLC for guidance.
Pro Numb Tattoo Numbing Spray was recalled on February 2, 2026 due to cGMP deviations. The product, containing 4% lidocaine, is distributed by Pro Numb Tattoo Numbing Spray LLC. Consumers should stop using it immediately and contact the company for further guidance.