FDA (Devices) recall action 96755

Silex Medical, LLC recalled 8 products on 2025-06-11

The FDA (Devices) publishes a recall like this one as 8 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 8 pages.

Products: 8
Announced: 2025-06-11
Critical: 0
Units: 169

Why these products were recalled

Insulation on the tube did 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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–8 of 8

HighFDA (Devices)··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.
Product
Signature Laparoscopic Instruments, Alligator Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5863050.
Category
Distribution
15 states
HighFDA (Devices)··2025-06-11
Signature Laparoscopic Sharp Tooth Grasper Insulation Defect Recall
Silex Medical recalls the Signature Laparoscopic Sharp Tooth Grasper due to incomplete insulation on the shaft near the rotator wheel, which creates an electrical hazard during use.
Product
Signature Laparoscopic Instruments, Sharp Tooth Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5863020.
Category
Distribution
15 states
HighFDA (Devices)··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.
Product
Signature Laparoscopic Instruments, Allis Clamp Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5862030.
Category
Distribution
15 states
HighFDA (Devices)··2025-06-11
Signature Laparoscopic Atraumatic Grasper Insulation Defect Recall
Silex Medical is recalling Signature Laparoscopic Instruments (Model 5881033) because insulation on the shaft does not fully extend to the proximal end, leaving an exposed area near the rotator wheel.
Product
Signature Laparoscopic Instruments, 20mm Atraumatic Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5881033.
Category
Distribution
15 states
HighFDA (Devices)··2025-06-11
Signature Laparoscopic Debakey Grasper Instruments Recalled for Insulation Defect
Silex Medical is recalling 8 units of Signature Laparoscopic Debakey Grasper instruments (Model 5862100) due to incomplete insulation on the shaft near the rotator wheel, which could expose the user or patient to electrical contact.
Product
Signature Laparoscopic Instruments, Debakey Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5862100.
Category
Distribution
15 states
HighFDA (Devices)··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.
Product
Signature Laparoscopic Instruments, Atraumatic Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5864000.
Category
Distribution
15 states
HighFDA (Devices)··2025-06-11
Signature Laparoscopic Dolphin Nose Grasper Instrument Insulation Defect
Silex Medical is recalling 2 units of a Signature Laparoscopic Instruments Dolphin Nose Grasper with Rotating Shaft due to incomplete insulation on the shaft, leaving an exposed area near the rotator wheel.
Product
Signature Laparoscopic Instruments, Dolphin Nose Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5860020.
Category
Distribution
15 states
HighFDA (Devices)··2025-06-11
Signature Laparoscopic Bullet Tip Grasper Instrument Insulation Defect Recall
Silex Medical is recalling 6 units of the Signature Laparoscopic Bullet Tip Grasper with Rotating Shaft due to incomplete insulation on the shaft near the rotator wheel, which could expose users to electrical hazards.
Product
Signature Laparoscopic Instruments, Bullet Tip Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5863030.
Category
Distribution
15 states