The FDA has posted 15 enforcement recalls of cutting & coagulation & accessories electrosurgical devices since 2025, none of them Class I (most serious). Most recent report: Sep 2, 2026.
Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.
There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
Getinge identified that Vasoview Hemopro 2 devices from Lot 3000547797 were exposed to an out-of-specification sterilization dose during a gamma sterilization run (Run ID 1183-28782A) performed by STERIS at its Whippany,…
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.
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.