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Intuitive Surgical Recalls
257 recalls on record · August 8, 2012 to July 22, 2026 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
January 22, 2025Medical DevicesFDA
Intuitive Surgical, Inc. recalls 8MM,CADIERE FORCEPS,IS4000 REF 471049
Hazard: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
January 22, 2025Medical DevicesFDA
Intuitive Surgical, Inc. recalls 8MM,LONG TIP FORCEPS,IS4000 REF 471048
Hazard: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
January 22, 2025Medical DevicesFDA
Intuitive Surgical, Inc. recalls 8MM,FORCE BIPOLAR,IS4000 REF 470405
Hazard: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
January 22, 2025Medical DevicesFDA
Intuitive Surgical, Inc. recalls 8MM,HORIZON SMALL CLIP APPLIER,IS4000¿ REF 470401
Hazard: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
January 22, 2025Medical DevicesFDA
Intuitive Surgical, Inc. recalls 8MM,TIP-UP FENESTRATED GRASPER,IS4000¿ REF 470347
Hazard: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
January 22, 2025Medical DevicesFDA
Intuitive Surgical, Inc. recalls 8MM,CURVED BIPOLAR DISSECTOR,IS4000¿ REF 470344
Hazard: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
January 22, 2025Medical DevicesFDA
Intuitive Surgical, Inc. recalls 8MM,MEDIUM-LARGE CLIP APPLIER,IS4000¿ REF 470327
Hazard: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
January 22, 2025Medical DevicesFDA
Intuitive Surgical, Inc. recalls 8MM,SMALL GRASPING RETRACTOR,IS4000¿ REF 470318
Hazard: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
January 22, 2025Medical DevicesFDA
Intuitive Surgical, Inc. recalls 8MM,MEGA SUTURECUT ND,IS4000¿ REF 470309
Hazard: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
January 22, 2025Medical DevicesFDA
Intuitive Surgical, Inc. recalls 8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000¿ REF 470296
Hazard: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
January 22, 2025Medical DevicesFDA
Intuitive Surgical, Inc. recalls 8MM,DUAL BLADE RETRACTOR,IS4000¿ REF 470249
Hazard: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
January 22, 2025Medical DevicesFDA
Intuitive Surgical, Inc. recalls 8MM,ATRIAL RETRACTOR SHORT RIGHT,IS4000¿ REF 470246
Hazard: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
January 22, 2025Medical DevicesFDA
Intuitive Surgical, Inc. recalls 8MM,LARGE HEM-O-LOK CLIP APPLIER,IS4000¿ REF 470230
Hazard: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
January 22, 2025Medical DevicesFDA
Intuitive Surgical, Inc. recalls 8MM,TENACULUM FORCEPS,IS4000¿ REF 470207
Hazard: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
January 22, 2025Medical DevicesFDA
Intuitive Surgical, Inc. recalls 8MM,FENESTRATED BIPOLAR FORCEPS,IS4000¿ REF 470205
Hazard: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
January 22, 2025Medical DevicesFDA
Intuitive Surgical, Inc. recalls 8MM,MEGA NEEDLE DRIVER,IS4000¿ REF 470194
Hazard: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
January 22, 2025Medical DevicesFDA
Intuitive Surgical, Inc. recalls 8MM,RESANO FORCEPS,IS4000 ¿ REF 470181
Hazard: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
January 22, 2025Medical DevicesFDA
Intuitive Surgical, Inc. recalls 8MM,MARYLAND BIPOLAR FORCEPS,IS4000 ¿ REF 470172
Hazard: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
January 22, 2025Medical DevicesFDA
Intuitive Surgical, Inc. recalls 8MM,MICRO BIPOLAR FORCEPS,IS4000 ¿ REF 470171
Hazard: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
January 22, 2025Medical DevicesFDA
Intuitive Surgical, Inc. recalls 8MM,PROGRASP FORCEPS,IS4000 ¿ REF 470093
Hazard: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
January 22, 2025Medical DevicesFDA
Intuitive Surgical, Inc. recalls 8MM,CADIERE FORCEPS,IS4000 ¿ REF 470049
Hazard: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
January 22, 2025Medical DevicesFDA
Intuitive Surgical, Inc. recalls 8MM,DEBAKEY FORCEPS,IS4000 ¿ REF 470036
Hazard: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
January 22, 2025Medical DevicesFDA
Intuitive Surgical, Inc. recalls 8MM,BLACK DIAMOND MICRO FORCEPS,IS4000 ¿ REF 470033
Hazard: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
January 22, 2025Medical DevicesFDA
Intuitive Surgical, Inc. recalls 8MM, ROUND TIP SCISSORS, IS4000 ¿ REF 470007
Hazard: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
January 22, 2025Medical DevicesFDA
Intuitive Surgical, Inc. recalls 8MM, LARGE NEEDLE DRIVER, IS4000 REF 470006
Hazard: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
January 22, 2025Medical DevicesFDA
Intuitive Surgical, Inc. recalls 8MM, POTTS SCISSORS, IS4000 REF 470001
Hazard: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
January 22, 2025Medical DevicesFDA
Intuitive Surgical, Inc. recalls 8MM, MONOPOLAR CURVED SCISSORS, IS4000 REF 470179
Hazard: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
September 4, 2024Medical DevicesFDA
Intuitive Surgical, Inc. recalls Ion Endoluminal System, REF: 380748-65
Hazard: There is a potential that the robotic system's instrument cart arm may contain screws that may potentially fail which could result in uncontrolled motion of a catheter inside a patient's airways.
April 17, 2024Medical DevicesFDA
Intuitive Surgical, Inc. recalls Patient Cart, Part: 380601, a component of the da Vinci SP Surgical System, Model: SP1098
Hazard: Surgical system may have inadequately welded top and/or bottom belts in the link 2 of the entry guide manipulator assembly/instrument arm joints, that may cause the following, 1) Top Failure: internal tissue injuries, body wall injury or emergent conversion to open surgery, 2) Bottom failure: pinching injury to the user with no harm to the patient.
December 6, 2023Medical DevicesFDA
Intuitive Surgical, Inc. recalls Da Vinci Single-Site Wristed Needle Driver, REF: 478115, 5 mm
Hazard: There is the potential for the needle drive to become dislodged and/or broken which could result in uncontrollable movement.