Silex Medical, LLC: Medical Device Recall in 2025 - (Recall #: Z-1895-2025)
See the recall detail below. You can also see other recalls from the same firm in 2025.
Signature Laparoscopic Instruments, Debakey Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5862100.
Class II
Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel.
Model/REF Number: 5862100. UDI-DI: B33158621000. Lot Number: M28183. Serial Numbers: 1932, 1933, 1934, 1935, 1936, 1937, 1938, 1939.
US Nationwide distribution in the states of Florida, North Dakota, Illinois, California, Texas, Virginia, Michigan, Connecticut, Oregon, Iowa, Mississippi, New Jersey, Idaho, West Virginia, Hawaii.
Voluntary: Firm initiated
