Silex Medical, LLC: Medical Device Recall in 2025 - (Recall #: Z-1896-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

Signature Laparoscopic Instruments, Sharp Tooth Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5863020.

Product Classification:

Class II

Date Initiated: January 9, 2024

Date Posted: June 11, 2025

Recall Number: Z-1896-2025

Event ID: 96755

Reason for Recall:

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.

Status: Ongoing

Product Quantity: 29 units

Code Information:

Model/REF Number: 5863020. UDI-DI: B33158630200. Lot Number: M28184. Serial Numbers: 2222, 2223, 2224, 2225, 2226, 2227, 2228, 2229, 2230, 2231, 2232, 2233, 2234, 2235, 2236, 2237, 2238, 2239, 2240, 2241, 2242, 2243, 2244, 2245, 2246, 2247, 2248, 2249, 2250, 2251, 2252, 2253

Distribution Pattern:

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 or Mandated:

Voluntary: Firm initiated