Recall archive
90 recalls · page 1 of 4
Reported Jul 22, 2026
da Vinci SP Instrument Arm Drape, SP, 1-PACK, Part Number: 430013-13, 430013-15
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intuitive Surgical, Inc.
Matched: Brand · Reason for recall — Robotic-assisted surgical system arm drapes may detach from the instrument arm due to an issue involving the drape rings located at the top of the…
FDA (openFDA device enforcement)
Reported Jul 1, 2026
Da Vinci ASSY, PSS, SP1098, Part Number: 380601
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intuitive Surgical, Inc.
Matched: Brand · Reason for recall — Operative components of surgical systems potentially distributed with E-brake retainer pin, so in event of a structural column failure, the E-brake…
FDA (openFDA device enforcement)
Reported Jun 10, 2026
Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746 Software Version: N/A Product…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intuitive Surgical, Inc.
Matched: Brand — Due to unintentionally activated near infrared handheld camera when attempting to turn off illumination during normal clinical workflow transitions,…
FDA (openFDA device enforcement)
Reported May 13, 2026
Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06
High riskUsing this product could cause serious injury, illness or death — stop using it now.Intuitive Surgical, Inc.
Matched: Brand · Product · Product details — Reloads for curved-tipped stapler may potentially produce an incomplete staple line.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 8, 2026
Brand Name: da Vinci S, Si Monopolar Curved Scissors Instrument Product Name: da Vinci S and Si Monopolar Curved…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intuitive Surgical, Inc.
Matched: Brand — Due to increased complaints for broken/frayed grip cables for reusable instruments.
5 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 25, 2026
Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used for minimally invasive surgery.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intuitive Surgical, Inc.
Matched: Brand · Reason for recall — An error event following the release of a software version for the surgical system that can result in loss of user interface content on an external…
FDA (openFDA device enforcement)
Reported Feb 18, 2026
da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Number: 380730-45
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intuitive Surgical, Inc.
Matched: Brand · Reason for recall — Robotic-assisted surgical system has Viewer Display manufactured with outdated firmware, may result in loss of one display-loss of 3D surgical field…
FDA (openFDA device enforcement)
Reported Feb 11, 2026
Brand Name: Da Vinci Product Name: da Vinci X, Xi Surgical System, & da Vinci 5 Surgical System Model/Catalog Number:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intuitive Surgical, Inc.
Matched: Brand · Product · Product details · Reason for recall — Due to a software implementation error that allowed instruments arms failing an important diagnostic test to remain in clinical use. This test was…
FDA (openFDA device enforcement)
Reported Jan 28, 2026
Brand Name: Ion Endoluminal System Product Name: Ion Vision Probe Bag Model/Catalog Number: 490127 Software Version:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intuitive Surgical, Inc.
Matched: Brand — Due to probe bags that may have a compromised or incomplete sterile pouch seal.
FDA (openFDA device enforcement)
Reported Jan 21, 2026
da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 (2.7-4cm,SP1098, Box) & 430075…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intuitive Surgical, Inc.
Matched: Brand — Access Port System tray may develop cracks potentially resulting in a sterility breach.
FDA (openFDA device enforcement)
Reported Dec 31, 2025
da Vinci 5, Surgeon Console Column Motor Connector; ASSY,DV5 CONSOLE,SSC,IS5000; Part Number: 380730-40
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intuitive Surgical, Inc.
Matched: Brand · Reason for recall — Surgical system Error 23062 due to connector1) Partially damaged "Potential problem with ergonomics: Disable - Retry " or 2) Failed "Disable…
FDA (openFDA device enforcement)
Reported Mar 19, 2025
Brand Name: Da Vinci 5 Product Name: ASSY,DV5 CONSOLE,IS5000 Foot Tray Pedals Model/Catalog Number: 380730 Software…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intuitive Surgical, Inc.
Matched: Brand — Due to an increase in complaints concerning foot tray pedal spring failing resulting in the pedal remaining pressed
FDA (openFDA device enforcement)
Reported Jan 22, 2025
8MM, MONOPOLAR CURVED SCISSORS, IS4000 REF 470179
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intuitive Surgical, Inc.
Matched: Brand — Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
38 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 4, 2024
Ion Endoluminal System, REF: 380748-65
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intuitive Surgical, Inc.
Matched: Brand — There is a potential that the robotic system's instrument cart arm may contain screws that may potentially fail which could result in uncontrolled…
FDA (openFDA device enforcement)
Reported Apr 17, 2024
Patient Cart, Part: 380601, a component of the da Vinci SP Surgical System, Model: SP1098
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intuitive Surgical, Inc.
Matched: Brand · Product · Product details · Reason for recall — Surgical system may have inadequately welded top and/or bottom belts in the link 2 of the entry guide manipulator assembly/instrument arm joints,…
FDA (openFDA device enforcement)
Reported Dec 6, 2023
Da Vinci Single-Site Wristed Needle Driver, REF: 478115, 5 mm
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intuitive Surgical, Inc.
Matched: Brand — There is the potential for the needle drive to become dislodged and/or broken which could result in uncontrollable movement.
FDA (openFDA device enforcement)
Reported Jul 12, 2023
da Vinci Xi/X Tip-Up Fenestrated Grasper, REF: 470347, VER: 12
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intuitive Surgical, Inc.
Matched: Brand — Fenestrated Graspers have a manufacturing issue has the potential to cause breakage on both upper and/or lower grips, which could lead to stainless…
FDA (openFDA device enforcement)
Reported Apr 5, 2023
da Vinci Xi Surgical System Model IS4000 da Vinci X Surgical System Model IS4200
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intuitive Surgical, Inc.
Matched: Brand · Product · Product details · Reason for recall — Due to Universal Surgical Manipulator (USM) instrument carriage being loose as a result of the linear rail component not being manufactured within…
FDA (openFDA device enforcement)
Reported Mar 22, 2023
Patient Side Cart, REF: 380620, with instrument arms, used as part of the da Vinci X Surgical System, REF: IS4200;…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intuitive Surgical, Inc.
Matched: Brand · Product · Product details · Reason for recall — Preventative maintenance data was used to identify instrument Arms, part of surgical systems, that allow surgeons to perform surgical tasks, that may…
FDA (openFDA device enforcement)
Reported Dec 7, 2022
INTUITIVE Da Vinci Xi 8mm SureForm 30 Curved-Tip Stapler Da Vinci Xi|X REF 488530 INTUITIVE Da Vinci 8mm SureForm 30…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intuitive Surgical, Inc.
Matched: Brand · Product · Product details — Potential staple deployment failure and device fragment generation
FDA (openFDA device enforcement)
Reported Nov 2, 2022
da Vinci X (IS4200) and Xi (IS4000) systems, which consists of finished devices Surgeon Console (SSC), Patient Cart…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intuitive Surgical, Inc.
Matched: Brand · Reason for recall — Inadvertent energy delivery from surgical system instrument if 1) Force bipolar and bipolar instruments installed on system 2) Force bipolar…
FDA (openFDA device enforcement)
Reported Aug 10, 2022
The E-100 Generator (PN 374848-09) is a bipolar electrosurgical unit (ESU) designed to be used with the da Vinci Xi and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intuitive Surgical, Inc.
Matched: Brand — Due to preventative maintenance (PM) not being performed on E-100 generators which is a bipolar electrosugical unit designed to be used with the da…
FDA (openFDA device enforcement)
Reported Aug 3, 2022
Da Vinci S/Si Large Clip Applier, Model 420230 Da Vinci S/Si Medium-Large Clip Applier, Model 420327 Da Vinci S/Si…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intuitive Surgical, Inc.
Matched: Brand — Due to the potential for unexpected motion caused by the partial disengagement of the instrument from the system.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 8, 2022
VESSEL SEALER EXTEND, Single-Use Instrument EndoWrist Instruments 8mm, da Vinci X' da Vinci Xi', REF 480422
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intuitive Surgical, Inc.
Matched: Brand — Placing excessive tissue in the instrument jaws of the devices prior to sealing and transection can result in an insufficient seal.
1 more product in this recall
FDA (openFDA device enforcement)
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