The Recall Desk
HighFDA (Devices)·Z-1899-2025·Announced 2025-06-11

Signature Laparoscopic Atraumatic Grasper Instrument Insulation Defect Recall

Silex Medical is recalling Signature Laparoscopic Atraumatic Grasper instruments (Model 5864000) due to incomplete insulation on the shaft that leaves an exposed area near the rotator wheel, posing an electrical safety risk during surgical use.

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 involving a surgical instrument with an electrical safety hazard (exposed conducting surface on a device used with monopolar electrosurgery). Although no reported injuries are stated in the source, the defect creates a direct risk of electrical injury during surgical procedures, meeting the High severity threshold for risk-of-harm products.

Plain-English summary

Silex Medical, LLC is recalling Signature Laparoscopic Instruments, Atraumatic Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector (Model/REF Number 5864000). The insulation on the tube does not extend fully to the proximal end of the shaft, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel.

A total of 105 units have been distributed nationwide. The affected devices are identified by Lot Number M28187 and serial numbers 9565 through 9670.

This recall affects devices distributed to Florida, North Dakota, Illinois, California, Texas, Virginia, Michigan, Connecticut, Oregon, Iowa, Mississippi, New Jersey, Idaho, West Virginia, and Hawaii. Healthcare facilities and surgical professionals in these states who have received this product should immediately cease use and contact the manufacturer for return and replacement instructions.

The recalled product

Product
Signature Laparoscopic Instruments, Atraumatic Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5864000.
Manufacturer
Silex Medical, LLC
Category
Medical Device — Surgical Instrument / Laparoscopic
Hazard
Affected units
105

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 (20)

  • 9566
  • 9567
  • 9568
  • 9569
  • 9570
  • 9571
  • 9572
  • 9573
  • 9574
  • 9575
  • 9576
  • 9577
  • 9578
  • 9579
  • 9580
  • 9581
  • 9582
  • 9583
  • 9584
  • 9585

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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