Agency classClass IIOur severity:High FDA (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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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: electrical-hazard
insulation-defect
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 →

Same manufacturer · Silex Medical, LLC

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Same hazard · electrical hazard