Manufacturer

Silex Medical, LLC

8 recalls in our database name Silex Medical, LLC as the manufacturing or recalling firm.

What the numbers show

Total: 8
Critical: 0
Severe: 0
Most recent: 2025-06-11

Of the 8 recalls from Silex Medical, LLC we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–8 of 8

HighFDA (Devices)·Z-1898-2025·2025-06-11
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
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1896-2025·2025-06-11
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
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1894-2025·2025-06-11
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
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1900-2025·2025-06-11
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
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1895-2025·2025-06-11
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
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1899-2025·2025-06-11
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
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1893-2025·2025-06-11
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
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1897-2025·2025-06-11
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
Medical Device
Distribution
Distributed nationwide