Olympus Corporation Of The Americas recalls Olympus Thunderbeat II Shears w/Ultrasonic Mode
Potential for detachment of a distal tip component of the device during use.
- Cutting & Coagulation & Accessories Electrosurgical
- Device Design
The FDA has posted 39 enforcement recalls of cutting & coagulation & accessories electrosurgical devices since 2025, including 2 Class I (most serious) recalls. Most recent report: Apr 29, 2026.
Potential for detachment of a distal tip component of the device during use.
Potential for detachment of a distal tip component of the device during use.
Potential for detachment of a distal tip component of the device during use.
Potential for detachment of a distal tip component of the device during use.
Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.
Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.
Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.
Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.
Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.
Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.
Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.
Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction.
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“Electrosurgical, Cutting & Coagulation & Accessories”). Informational only — verify against the FDA before acting.