The Recall Desk
HighFDA (Devices)·Z-1898-2025·Announced 2025-06-11

Signature Laparoscopic Alligator Grasper Instrument Recall Safety Issue

Silex Medical is recalling the Signature Laparoscopic Alligator Grasper with Rotating Shaft (Model 5863050) because insulation on the tube does not fully extend to the proximal end of the shaft, leaving an exposed uninsulated area near the rotator wheel.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of a surgical instrument with a defect involving electrical insulation failure. The exposed conductive area presents a risk of electrical harm during surgical use, which qualifies as a risk-of-harm product defect where injury has not yet been reported.

Plain-English summary

Silex Medical, LLC is recalling the Signature Laparoscopic Instruments, Alligator Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector (Model/REF Number: 5863050). The recall affects 7 units distributed nationwide to Florida, North Dakota, Illinois, California, Texas, Virginia, Michigan, Connecticut, Oregon, Iowa, Mississippi, New Jersey, Idaho, West Virginia, and Hawaii.

The defect involves incomplete insulation on the tube. The insulation does not extend fully to the proximal end of the shaft, creating an exposed (uninsulated) area of the shaft closer to the rotator wheel.

If you have received this device, contact Silex Medical, LLC for instructions on how to proceed. Do not use the affected instruments until guidance has been obtained from the manufacturer.

The recalled product

Product
Signature Laparoscopic Instruments, Alligator Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5863050.
Manufacturer
Silex Medical, LLC
Category
Medical Device — Surgical Instrument / Laparoscopic
Hazard
Affected units
7

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (8)

  • 1052
  • 1053
  • 1054
  • 1055
  • 1056
  • 1057
  • 1058
  • 1059

Distribution

Distributed nationwide across the United States.

The notice also names 15 states specifically:

Part of a larger recall action

This product is one of 8 recalled by Silex Medical, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 8 products in this recall →

Related recalls

Same manufacturer · Silex Medical, LLC

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Same hazard · electrical hazard

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