Intuitive Surgical, Inc.
46 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Intuitive Surgical, Inc. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-01-22FDA-DeviceClass II8MM,MARYLAND BIPOLAR FORCEPS,IS4000 ¿ REF 470172
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- 2025-01-22FDA-DeviceClass II8MM,MICRO BIPOLAR FORCEPS,IS4000 ¿ REF 470171
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- 2025-01-22FDA-DeviceClass II8MM,PROGRASP FORCEPS,IS4000 ¿ REF 470093
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- 2025-01-22FDA-DeviceClass II8MM,CADIERE FORCEPS,IS4000 ¿ REF 470049
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- 2025-01-22FDA-DeviceClass II8MM,DEBAKEY FORCEPS,IS4000 ¿ REF 470036
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- 2025-01-22FDA-DeviceClass II8MM,BLACK DIAMOND MICRO FORCEPS,IS4000 ¿ REF 470033
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- 2025-01-22FDA-DeviceClass II8MM, ROUND TIP SCISSORS, IS4000 ¿ REF 470007
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- 2025-01-22FDA-DeviceClass II8MM, LARGE NEEDLE DRIVER, IS4000 REF 470006
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- 2025-01-22FDA-DeviceClass II8MM, POTTS SCISSORS, IS4000 REF 470001
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- 2025-01-22FDA-DeviceClass II8MM, MONOPOLAR CURVED SCISSORS, IS4000 REF 470179
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- 2024-09-04FDA-DeviceClass IIIon Endoluminal System, REF: 380748-65
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.
- 2024-04-17FDA-DeviceClass IIPatient Cart, Part: 380601, a component of the da Vinci SP Surgical System, Model: SP1098
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.
- 2023-12-06FDA-DeviceClass IIDa Vinci Single-Site Wristed Needle Driver, REF: 478115, 5 mm
There is the potential for the needle drive to become dislodged and/or broken which could result in uncontrollable movement.
- 2023-07-12FDA-DeviceClass IIda Vinci Xi/X Tip-Up Fenestrated Grasper, REF: 470347, VER: 12
Fenestrated Graspers have a manufacturing issue has the potential to cause breakage on both upper and/or lower grips, which could lead to stainless steel fragments falling into the patient that may be either detected or undetected.
- 2023-04-05FDA-DeviceClass IIda Vinci Xi Surgical System Model IS4000 da Vinci X Surgical System Model IS4200
Due to Universal Surgical Manipulator (USM) instrument carriage being loose as a result of the linear rail component not being manufactured within specifications.
- 2023-03-22FDA-DeviceClass IIPatient Side Cart, REF: 380620, with instrument arms, used as part of the da Vinci X Surgical System, REF: IS4200; Patient Side Cart, REF: 380652, with instrument arms, used as part of the da Vinci Xi Surgical System, REF: IS4000
Preventative maintenance data was used to identify instrument Arms, part of surgical systems, that allow surgeons to perform surgical tasks, that may be at risk of insertion ballscrew failure, allowing for uncontrolled carriage movement along the insertion axis, which may cause tissue injury.
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