The Recall Desk
HighFDA (Devices)·Z-1894-2025·Announced 2025-06-11

Signature Laparoscopic Allis Clamp Grasper with Rotating Shaft Recalled

Silex Medical is recalling the Signature Laparoscopic Instruments Allis Clamp Grasper due to incomplete insulation on the shaft, leaving an exposed area that could pose an electrical hazard during surgical procedures.

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 an electrical safety defect (exposed shaft insulation). Although no injuries or illnesses are reported in the source text, the defect presents a risk of electrical injury in a high-risk surgical environment, meeting the High/Score 3 criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Silex Medical, LLC is recalling the Signature Laparoscopic Instruments, Allis Clamp Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector (Model/REF Number 5862030). The recall affects 10 units distributed nationwide to facilities in Florida, North Dakota, Illinois, California, Texas, Virginia, Michigan, Connecticut, Oregon, Iowa, Mississippi, New Jersey, Idaho, West Virginia, and Hawaii.

The insulation on the tube does 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. This defect was identified in units with Lot Number M28182, Serial Numbers 0709 through 0720.

Healthcare facilities and personnel using this instrument should discontinue use immediately. Silex Medical, LLC advises contacting the company or the FDA with any questions or to report adverse events associated with this device.

The recalled product

Product
Signature Laparoscopic Instruments, Allis Clamp Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5862030.
Manufacturer
Silex Medical, LLC
Category
Medical Device — Surgical Instrument
Hazard
Affected units
10

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 (11)

  • 0710
  • 0711
  • 0712
  • 0713
  • 0714
  • 0715
  • 0716
  • 0717
  • 0718
  • 0719
  • 0720

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 shock

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