Manufacturer
75 recalls in our database name Intuitive Surgical, Inc. as the manufacturing or recalling firm.
The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.
Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.
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 recalls ProGrasp Forceps instruments due to increased complaints of frayed or broken grip cables. Approximately 99,249 units distributed in the U.S. and internationally are affected.
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 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 the Ion Endoluminal System due to potential screw failure in the instrument cart arm, which could cause uncontrolled catheter motion in patient airways.
Intuitive Surgical recalled 53 da Vinci SP Surgical System Patient Carts due to inadequate welds in the instrument arm joints. These welds may cause tissue injuries, conversion to open surgery, or user pinching injuries.
Intuitive Surgical is recalling 317 units of a Da Vinci Single-Site Wristed Needle Driver due to potential dislodgement or breakage that could result in uncontrollable movement.
Intuitive Surgical is recalling 46,033 da Vinci Xi/X Tip-Up Fenestrated Graspers worldwide due to a manufacturing issue that can cause grip breakage, potentially allowing stainless steel fragments to enter the patient.
Intuitive Surgical is recalling da Vinci Xi and da Vinci X surgical systems because the instrument carriage can become loose due to a manufacturing defect in the linear rail component.
Intuitive Surgical recalls Patient Side Carts for da Vinci X and Xi surgical systems due to ballscrew failure risk. The failure could cause uncontrolled carriage movement leading to potential tissue injury during surgery. 9 units affected.
Intuitive Surgical is recalling Da Vinci Xi surgical stapling instruments due to potential staple deployment failure and device fragment generation. No injuries have been reported.
Intuitive Surgical's da Vinci X and Xi surgical systems can inadvertently deliver electrical energy to patients under specific instrument and pedal combinations, creating a risk during surgery.
Intuitive Surgical is recalling 505 E-100 electrosurgical generators because required preventative maintenance was not performed on units distributed worldwide and in the US.
Intuitive Surgical is recalling 62,895 Da Vinci S/Si Clip Appliers worldwide due to potential unexpected motion from partial instrument disengagement. No injuries or illnesses have been reported.
Intuitive Surgical is recalling three models of Da Vinci clip appliers due to potential unexpected motion from partial instrument disengagement. Approximately 90,628 units have been distributed worldwide.
Intuitive Surgical is recalling da Vinci Vessel Sealer instruments worldwide because placing excessive tissue in the instrument jaws can result in an insufficient seal. Surgeons should follow proper technique guidelines when using the device.
Intuitive Surgical recalls da Vinci Energy SynchroSeal surgical instruments due to potential seal failure. Excessive tissue in the instrument jaws can result in insufficient sealing.
Intuitive Surgical recalled SureForm surgical staplers after tissue pushout events caused unexpected bleeding during procedures. The actual harm rate exceeded safety predictions.
Intuitive Surgical is recalling the da Vinci Xi and X 12-8 mm Conductive Cannula Reducer because the metal tip may dislodge from the plastic shaft. If unnoticed, additional surgery may be needed, or energy leakage could cause tissue damage.
Intuitive Surgical recalls 46 da Vinci SP Surgical systems due to software defect causing potential failure or inadvertent delivery of surgical energy. Issue may require surgeon intervention during procedures.
Intuitive Surgical recalls 1,740 da Vinci Instrument Arm Drapes due to incorrect expiration dates on package labeling. The error may prevent accurate verification of sterility assurance dates.
Intuitive Surgical recalled 1,625 Ion Flexison Biopsy Needles due to potential sheath tip separation from the shaft. Affected units are distributed across 29 US states and China; no injuries have been reported.