Home / Recalls / Silex Medical, LLC / Z-1894-2025

Z-1894-2025 Class II Ongoing

Recalled by Silex Medical, LLC — Southington, CT

Recall Details

Product Type
Devices
Report Date
June 11, 2025
Initiation Date
January 9, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
10 units

Product Description

Signature Laparoscopic Instruments, Allis Clamp Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5862030.

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.

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.

Code Information

Model/REF Number: 5862030. UDI-DI: B33158620300. Lot Number: M28182. Serial Numbers: 0709, 0710, 0711, 0712, 0713, 0714, 0715, 0716, 0717, 0718, 0719, 0720

Other recalls by Silex Medical, LLC

  • Z-1900-2025 Class II — Signature Laparoscopic Instruments, 20mm Atraumatic Grasper with Rotating Shaft (January 9, 2024)
  • Z-1896-2025 Class II — Signature Laparoscopic Instruments, Sharp Tooth Grasper with Rotating Shaft and (January 9, 2024)
  • Z-1897-2025 Class II — Signature Laparoscopic Instruments, Bullet Tip Grasper with Rotating Shaft and M (January 9, 2024)
  • Z-1899-2025 Class II — Signature Laparoscopic Instruments, Atraumatic Grasper with Rotating Shaft and M (January 9, 2024)
  • Z-1898-2025 Class II — Signature Laparoscopic Instruments, Alligator Grasper with Rotating Shaft and Mo (January 9, 2024)
  • Z-1893-2025 Class II — Signature Laparoscopic Instruments, Dolphin Nose Grasper with Rotating Shaft and (January 9, 2024)
  • Z-1895-2025 Class II — Signature Laparoscopic Instruments, Debakey Grasper with Rotating Shaft and Mono (January 9, 2024)