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 reusable surgical instruments due to reports of frayed or broken grip cables that may affect safe operation during procedures.
Intuitive Surgical is recalling 8MM Mega Suturecut ND surgical instruments due to increased complaints of frayed or broken grip cables that may affect instrument operation.
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, 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 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 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 1,739 8MM DeBakey Forceps (Model 470036) used in surgical procedures due to increased reports of frayed or broken grip cables. Cable failure could impair instrument function during surgery.
Intuitive Surgical is recalling 2,852 units of 8MM Prograsp Forceps due to complaints of frayed or broken grip cables. These reusable surgical instruments may lose grip control during use.
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 recalls 8MM Fenestrated Bipolar Forceps due to increased complaints about frayed or broken grip cables on 12,340 units distributed nationwide and internationally.
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 recalls 355,547 monopolar curved scissors due to increased complaints of frayed or broken grip cables on these reusable surgical instruments.