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
- Hazard
- electrical-hazard
- insulation-defect
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.
Related recalls
Same category
- HighMedtronic DLP One-Piece Pediatric Arterial Cannula Recalled for Foreign Material
FDA (Devices) · 2026-07-22
- SevereAbiomed Impella CP Smart Assist Set Heart Pump Introducer Sheath Leakage
FDA (Devices) · 2026-07-22
- SevereMedtronic Bio-Medicus Adult Cannula Kit Recalled for Foreign Material
FDA (Devices) · 2026-07-22
- HighVasoview Hemopro 2 Endoscopic Vessel Harvesting System Recall
FDA (Devices) · 2026-07-22
- HighMobile Digital Radiographic System Arm Drop Risk During Patient Exams
FDA (Devices) · 2026-07-22