FDAJanuary 9, 2024device
Signature Laparoscopic Instruments, Sharp Tooth Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5863020.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Ongoing
Brands named
silex medicalsilex
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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