FDA (Devices) recall action 69638
The FDA (Devices) publishes a recall like this one as 22 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 22 pages.
Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.
Deviations in reprocessing steps from those stated in the reprocessing instructions, can cause surface degradation of the housing; and/or, accelerate mechanical wear of the instrument.
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.
Intuitive Surgical is recalling 509 units of 8mm Curved Bipolar Dissectors because deviations in reprocessing steps can cause surface degradation and mechanical wear.
Intuitive Surgical is recalling 509 units of 8mm clip appliers because deviations in reprocessing steps can cause surface degradation and mechanical wear.
Intuitive Surgical is recalling 509 units of 8mm Dual Blade Retractors because deviations in reprocessing steps can cause surface degradation and accelerated mechanical wear.
Intuitive Surgical is recalling 509 8mm Large Needle Driver instruments due to potential surface degradation and accelerated mechanical wear caused by reprocessing deviations.
Intuitive Surgical is recalling 509 8mm Resano Forceps instruments because deviations in reprocessing steps can cause surface degradation and accelerated mechanical wear.
Intuitive Surgical is recalling 509 units of 8mm Micro Bipolar Forceps because deviations in reprocessing steps can cause surface degradation and mechanical wear.
Intuitive Surgical is recalling 509 8mm Permanent Cautery Hooks because deviations in reprocessing steps can cause surface degradation and accelerated mechanical wear.
Intuitive Surgical is recalling 509 8mm Potts Scissors because deviations in reprocessing steps can cause surface degradation and accelerated mechanical wear.
Intuitive Surgical is recalling 509 units of 8mm Long Tip Forceps because deviations in reprocessing steps can cause surface degradation and accelerated mechanical wear.
Intuitive Surgical is recalling 509 units of 8mm Tip-Up Fenestrated Graspers because deviations in reprocessing steps can cause surface degradation and mechanical wear.
Intuitive Surgical is recalling 509 units of 8mm Tenaculum Forceps because deviations in reprocessing steps can cause surface degradation and accelerated mechanical wear.
Intuitive Surgical is recalling 509 units of the 8mm Small Grasping Retractor because deviations in reprocessing steps can cause surface degradation and mechanical wear.
Intuitive Surgical is recalling 8mm ProGrasp Forceps because deviations in reprocessing steps can cause surface degradation and accelerated mechanical wear.
Intuitive Surgical is recalling 509 units of 8mm Atrial Retractor Short Right instruments because deviations in reprocessing steps can cause surface degradation and accelerated mechanical wear.
Intuitive Surgical is recalling 509 units of 8mm Monopolar Curved Scissors because deviations in reprocessing steps can cause surface degradation and mechanical wear.
Intuitive Surgical is voluntarily recalling 509 units of 8mm Large Hem-O-Lok Clip Appliers due to a Class II device defect. The affected instruments were distributed to facilities in eight US states.
Intuitive Surgical is recalling 509 units of 8mm MEGA SUTURECUT ND instruments due to potential surface degradation and accelerated mechanical wear.
Intuitive Surgical is recalling 8mm Maryland Bipolar Forceps because deviations in reprocessing steps can cause surface degradation and accelerated mechanical wear.
Intuitive Surgical is recalling 509 units of 8mm Black Diamond Micro Forceps because deviations in reprocessing steps can cause surface degradation and accelerated mechanical wear.
Intuitive Surgical is recalling 509 units of 8mm Permanent Cautery Spatulas because deviations in reprocessing steps can cause surface degradation of the housing and accelerate mechanical wear.
Intuitive Surgical is recalling 509 units of 8mm Fenestrated Bipolar Forceps because deviations in reprocessing steps can cause surface degradation and accelerated mechanical wear.
Intuitive Surgical is recalling 509 units of 8mm Cardiac Probe Graspers because deviations in reprocessing steps can cause surface degradation and accelerated mechanical wear.