Silex Medical, LLC
8 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Silex Medical, LLC and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-06-11FDA-DeviceClass IISignature Laparoscopic Instruments, 20mm Atraumatic Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5881033.
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.
- 2025-06-11FDA-DeviceClass IISignature Laparoscopic Instruments, Atraumatic Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5864000.
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.
- 2025-06-11FDA-DeviceClass IISignature Laparoscopic Instruments, Alligator Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5863050.
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.
- 2025-06-11FDA-DeviceClass IISignature Laparoscopic Instruments, Bullet Tip Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5863030.
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.
- 2025-06-11FDA-DeviceClass IISignature Laparoscopic Instruments, Sharp Tooth Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5863020.
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.
- 2025-06-11FDA-DeviceClass IISignature Laparoscopic Instruments, Debakey Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5862100.
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.
- 2025-06-11FDA-DeviceClass IISignature Laparoscopic Instruments, Allis Clamp Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5862030.
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.
- 2025-06-11FDA-DeviceClass IISignature Laparoscopic Instruments, Dolphin Nose Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5860020.
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.
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