FDA (Devices) recall action 95938
The FDA (Devices) publishes a recall like this one as 37 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 37 pages.
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
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 8MM Large Suture Cut Needle Drivers (Model 471296) due to complaints of frayed or broken grip cables. Affected instruments may lose functionality during surgical use.
Intuitive Surgical recalls 1,036 units of 8MM Micro Bipolar Forceps due to increased complaints of frayed or broken grip cables that could affect instrument function during surgical procedures.
Intuitive Surgical, Inc. is recalling 8MM Force Bipolar surgical instruments due to increased complaints of frayed or broken grip cables on the reusable instruments.
Intuitive Surgical is recalling 29,559 units of the 8MM Large HEM-O-LOK Clip Applier for frayed or broken grip cables on the reusable surgical instrument jaws.
Intuitive Surgical is recalling 141 curved bipolar dissectors due to complaints of frayed or broken grip cables on the reusable surgical instruments.
Intuitive Surgical is recalling 8MM Potts Scissors due to frayed or broken grip cables that could affect instrument performance during surgical procedures.
Intuitive Surgical has recalled approximately 30,316 units of its 8MM Medium-Large Clip Applier instruments (Model 470327) due to reports of frayed or broken grip cables on the reusable surgical tools.
Intuitive Surgical is recalling 178 units of its 8MM Micro Bipolar Forceps (Model 470171) due to increased complaints of frayed or broken grip cables on the reusable instruments. Affected devices have been distributed nationwide and internationally.
Intuitive Surgical is recalling approximately 9,303 units of 8MM Small Grasping Retractor instruments due to increased complaints of frayed or broken grip cables affecting reusable surgical instruments distributed nationwide and internationally.
Intuitive Surgical is recalling 8MM Large Suturecut Needle Driver instruments due to frayed or broken grip cables. The recall affects 784 units distributed nationwide and internationally.
Intuitive Surgical is recalling 2,472 Cobra Grasper surgical instruments due to frayed or broken grip cables that may affect surgical procedures.
Intuitive Surgical is recalling 147,006 units of 8MM Fenestrated Bipolar Forceps due to increased complaints of frayed or broken grip cables, which could impair surgical control.
Intuitive Surgical is recalling 5,576 units of the 8MM Horizon Small Clip Applier due to complaints of frayed or broken grip cables on the reusable instruments.
Intuitive Surgical is recalling its 8MM Tip-Up Fenestrated Grasper due to frayed or broken grip cables on reusable surgical instruments. The defect affects multiple batch numbers produced between 2023 and 2024.
Intuitive Surgical is recalling 56,580 units of the 8mm Cadiere Forceps (Model 471049) due to increased complaints of frayed or broken grip cables on the reusable surgical instrument.
Intuitive Surgical is recalling 68,458 units of its 8MM Maryland Bipolar Forceps due to increased complaints about frayed or broken grip cables on the reusable surgical instruments.
Intuitive Surgical is recalling 38,438 units of the 8MM Mega Needle Driver surgical instruments due to complaints of frayed or broken grip cables.
Intuitive Surgical is recalling 8MM Black Diamond Micro Forceps (Model 470033) due to complaints of frayed or broken grip cables. The defect affects 1,111 units distributed nationwide and internationally.
Intuitive Surgical is recalling 11,162 units of 8MM Tenaculum Forceps (Model 470207) due to increased complaints of frayed or broken grip cables on reusable surgical instruments. Users should discontinue use immediately.
Intuitive Surgical is recalling approximately 46,759 8MM Force Bipolar IS4000 surgical instruments nationwide and internationally due to reports of frayed or broken grip cables that could compromise instrument function during surgical use.
Intuitive Surgical is recalling 8MM Dual Blade Retractors due to increased complaints of frayed or broken grip cables. This defect affects 783 reusable surgical instruments distributed in the U.S. and internationally.
Intuitive Surgical is recalling 8,578 units of Cadiere Forceps surgical instruments due to reports of frayed or broken grip cables. These reusable instruments were distributed throughout the United States and internationally.
Intuitive Surgical is recalling 4,259 units of 8MM round tip scissors due to complaints of frayed or broken grip cables. The defect could affect instrument reliability during surgical procedures.
Intuitive Surgical is recalling 373 Resano Forceps due to increased complaints of frayed or broken grip cables on the reusable surgical instruments. Affected healthcare providers should contact the manufacturer for guidance.
Intuitive Surgical recalls 8MM Large Needle Driver instruments (Model 470006) due to frayed or broken grip cables affecting reusable instrument function during surgery.