Intuitive Surgical recalls
32 official recalls and safety alerts involving Intuitive Surgical since 2021-10, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Intuitive Surgical or the relevant agency.
- 2026-07-22
USIntuitive Surgical, Inc. recalls da Vinci SP Instrument Arm Drape, SP, 1-PACK, Part Number: 430013-13, 430013-15
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 product, which may expose a section of instrument arm, which may result…
FDA · DeviceIntuitive Surgical, Inc.Worldwide - US Nationwide distribution in the states of NJ, OR, NY, FL, AL,…Official notice →- 2026-07-01
- US
Intuitive Surgical, Inc. recalls Da Vinci ASSY, PSS, SP1098, Part Number: 380601
Operative components of surgical systems potentially distributed with E-brake retainer pin, so in event of a structural column failure, the E-brake pin would prevent E-brake engagement and may result in uncontrolled…
FDA · DeviceIntuitive Surgical, Inc.Worldwide - US Nationwide distribution including in the states of CA, GA, OH,…Official notice → - 2026-06-10
- US
Intuitive Surgical, Inc. recalls Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746 Software Version: N/A Product Description:…
Due to unintentionally activated near infrared handheld camera when attempting to turn off illumination during normal clinical workflow transitions, particularly when switching from the handheld camera to the robotic…
FDA · DeviceIntuitive Surgical, Inc.U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA,…Official notice → - 2026-05-13
- US
Intuitive Surgical, Inc. recalls Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X, Xi Surgical System Model/Catalog Number: IS4000; IS4200 Software…
Due to manipulator containing screws with in the arm sub-assembly that my be susceptible to breaking.
FDA · DeviceIntuitive Surgical, Inc.Worldwide - U.S. Nationwide distribution including in the states of AK, AL,…Official notice → - US
Intuitive Surgical, Inc. recalls Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06
Reloads for curved-tipped stapler may potentially produce an incomplete staple line.
FDA · DeviceIntuitive Surgical, Inc.US: Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware…Official notice → - 2026-04-08
- US
Intuitive Surgical, Inc. recalls Brand Name: da Vinci S, Si Permanent Cautery Hook Instrument Product Name: da Vinci S, Si Permanent Cautery Hook Instrument…
Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments
FDA · DeviceIntuitive Surgical, Inc.U.S. Nationwide distribution in the states of AR, CA, CT, FL, IA, IL, IN, KS,…Official notice → - US
Intuitive Surgical, Inc. recalls Brand Name: da Vinci S, Si Mega Needle Driver Instrument Product Name: da Vinci S, Si Mega Needle Driver Instrument Model/Catalog…
Due to increased complaints for broken/frayed grip cables for reusable instruments.
FDA · DeviceIntuitive Surgical, Inc.Worldwide - U.S. Nationwide distribution in the states of CA, FL, GA, IA, IL,…Official notice → - 2026-02-25
- US
Intuitive Surgical, Inc. recalls Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used for minimally invasive surgery.
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 monitor or tower monitor.
- 2026-02-18
- US
Intuitive Surgical, Inc. recalls da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Number: 380730-45
Robotic-assisted surgical system has Viewer Display manufactured with outdated firmware, may result in loss of one display-loss of 3D surgical field (depth perception) but 2D maintained, or loss of both…
FDA · DeviceIntuitive Surgical, Inc.US Nationwide distribution in the states of KS, AZ, MA, FL, MI, NC, IL, DC,…Official notice → - 2026-02-11
- US
Intuitive Surgical, Inc. recalls Brand Name: Da Vinci Product Name: da Vinci X, Xi Surgical System, & da Vinci 5 Surgical System Model/Catalog Number: IS4000; IS4200;…
Due to a software implementation error that allowed instruments arms failing an important diagnostic test to remain in clinical use. This test was supposed to be used to detect Universal Surgical Manipulator insertion…
FDA · DeviceIntuitive Surgical, Inc.U.S.: AL, AR, CA, CO, CT, FL, ID, IL, IN, KS, KY, MD, MI, MN, MS, MO, NC, NJ,…Official notice → - 2026-01-28
- US
Intuitive Surgical, Inc. recalls Brand Name: Ion Endoluminal System Product Name: Ion Vision Probe Bag Model/Catalog Number: 490127 Software Version: N/A Product…
Due to probe bags that may have a compromised or incomplete sterile pouch seal.
FDA · DeviceIntuitive Surgical, Inc.U.S.: AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY,…Official notice → - 2026-01-21
- US
Intuitive Surgical, Inc. recalls da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 (2.7-4cm,SP1098, Box) & 430075 (2.7-7cm,SP1098,Box)
Access Port System tray may develop cracks potentially resulting in a sterility breach.
FDA · DeviceIntuitive Surgical, Inc.Worldwide - US Nationwide distribution including in the states of Alabama,…Official notice → - 2025-12-31
- US
Intuitive Surgical, Inc. recalls da Vinci 5, Surgeon Console Column Motor Connector; ASSY,DV5 CONSOLE,SSC,IS5000; Part Number: 380730-40
Surgical system Error 23062 due to connector1) Partially damaged "Potential problem with ergonomics: Disable - Retry " or 2) Failed "Disable Ergonomics: Viewer, headrest, armrest, and pedal tray position cannot be…
FDA · DeviceIntuitive Surgical, Inc.US Nationwide distribution in the states of MN, FL, CO, CA, NC, KS, TX, SC,…Official notice → - 2025-03-19
- US
Intuitive Surgical, Inc. recalls Brand Name: Da Vinci 5 Product Name: ASSY,DV5 CONSOLE,IS5000 Foot Tray Pedals Model/Catalog Number: 380730 Software Version: N/A . Refer…
Due to an increase in complaints concerning foot tray pedal spring failing resulting in the pedal remaining pressed
FDA · DeviceIntuitive Surgical, Inc.Worldwide distribution - US Nationwide and the countries of Alaska, Arizona,…Official notice → - 2025-01-22
- US
Intuitive Surgical, Inc. recalls 8MM, Small Graptor REF 470318 Is a grasping retractor Instrument used with the da Vinci X/Xi Surgical Systems in a wide variety of…
Due to an increase in complaints for pitch cable failures related to forceps and small Graptor instruments
FDA · DeviceIntuitive Surgical, Inc.U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA,…Official notice → - US
Intuitive Surgical, Inc. recalls 8MM,HORIZON SMALL CLIP APPLIER,IS4000¿ REF 470401
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
FDA · DeviceIntuitive Surgical, Inc.U.S. - Nation-wide. Alabama, Alaska, Arizona, Arkansas, California, Colorado,…Official notice → - 2024-09-04
- US
Intuitive Surgical, Inc. recalls Ion 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.
FDA · DeviceIntuitive Surgical, Inc.US Nationwide distribution in the states of AZ and CA.Official notice → - 2024-04-17
- US
Intuitive Surgical, Inc. recalls Patient 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,…
FDA · DeviceIntuitive Surgical, Inc.US: VA, CA, NH, FL, NY, CO, AL, KY, MD, NC, NJ, OH, SC, SD, TN, WA, WI, WV,…Official notice → - 2023-12-06
- US
Intuitive Surgical, Inc. recalls Da 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.
FDA · DeviceIntuitive Surgical, Inc.US: IL, FL, ID, SC, MI, TX, TN, NY, OR, CO, CA, MS, NJ, Puerto Rico OUS: South…Official notice → - 2023-07-12
- US
Intuitive Surgical, Inc. recalls da 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…
FDA · DeviceIntuitive Surgical, Inc.Worldwide - US Nationwide distribution in the states of PR, FL, MN, PA, AZ,…Official notice → - 2023-04-05
- US
Intuitive Surgical, Inc. recalls da 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.
FDA · DeviceIntuitive Surgical, Inc.U.S.: Cayman Islands, Dominican Republic, Puerto Rico, United States O.U.S.:…Official notice → - 2023-03-22
- US
Intuitive Surgical, Inc. recalls Patient Side Cart, REF: 380620, with instrument arms, used as part of the da Vinci X Surgical System, REF: IS4200; Patient Side Cart,…
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…
FDA · DeviceIntuitive Surgical, Inc.Worldwide - US Nationwide distribution in the states of FL, GA, WA and the…Official notice → - 2022-12-07
- US
Intuitive Surgical, Inc. recalls INTUITIVE Da Vinci Xi 8mm SureForm 30 Curved-Tip Stapler Da Vinci Xi|X REF 488530 INTUITIVE Da Vinci 8mm SureForm 30 Reload 30 mm Gray…
Potential staple deployment failure and device fragment generation
FDA · DeviceIntuitive Surgical, Inc.U.S.: Arizona, California, Colorado, Florida, Illinois, Indiana, Louisiana,…Official notice → - 2022-11-02
- US
Intuitive Surgical, Inc. recalls da Vinci X (IS4200) and Xi (IS4000) systems, which consists of finished devices Surgeon Console (SSC), Patient Cart (PSCART), Vision…
Inadvertent energy delivery from surgical system instrument if 1) Force bipolar and bipolar instruments installed on system 2) Force bipolar connected to Force Triad generator, bipolar not connected to generator 3)…
FDA · DeviceIntuitive Surgical, Inc.US: MS, PA, WI, KY, TN, MI, FL, GA, NC, NV, LA, OH, IL, MO, IN, CA, AK, MD,…Official notice → - 2022-08-10
- US
Intuitive Surgical, Inc. recalls The E-100 Generator (PN 374848-09) is a bipolar electrosurgical unit (ESU) designed to be used with the da Vinci Xi and X systems. The…
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 Vinci Xi and X systems.
FDA · DeviceIntuitive Surgical, Inc.Worldwide distribution - U.S. Nationwide distribution in the states of AL, AK,…Official notice → - 2022-08-03
- US
Intuitive Surgical, Inc. recalls Da Vinci S/Si Large Clip Applier, Model 420230 Da Vinci S/Si Medium-Large Clip Applier, Model 420327 Da Vinci S/Si Small Clip Applier,…
Due to the potential for unexpected motion caused by the partial disengagement of the instrument from the system.
FDA · DeviceIntuitive Surgical, Inc.Worldwide distribution - U.S. Nationwide distribution in the states of AL, AK,…Official notice → - 2022-06-08
- US
Intuitive Surgical, Inc. recalls VESSEL SEALER EXTEND, Single-Use Instrument EndoWrist Instruments 8mm, da Vinci X' da Vinci Xi', REF 480422
Placing excessive tissue in the instrument jaws of the devices prior to sealing and transection can result in an insufficient seal.
FDA · DeviceIntuitive Surgical, Inc.Worldwide distribution - US Nationwide and the countries/regions of Argentina,…Official notice → - 2022-05-04
- US
Intuitive Surgical, Inc. recalls da Vinici X da Vinci Xi Sureform 45 REF 480445 da Vinci X da Vinci Xi Sureform 45 Curved-Tip REF 480545 da Vinici X da Vinci Xi Sureform…
As a result of complaint data review, it identified tissue pushout events occurring during firing of the SureForm stapler when tissue is pushed distally within the jaws, rather than being held in place and transected.…
FDA · DeviceIntuitive Surgical, Inc.Worldwide distribution - U.S. Nationwide distribution in the states of AL, AK,…Official notice → - 2022-03-09
- US
Intuitive Surgical, Inc. recalls da Vinci Xi and X 12-8 mm Conductive Cannula Reducer, REF: 470381-11
Conductive Cannula Reducer metal tip may get dislodged from the plastic shaft. If unnoticed, additional surgery may be required to remove the metal tip. If the procedure proceeds without the metal tip, there is…
FDA · DeviceIntuitive Surgical, Inc.Worldwide distribution - US Nationwide distribution in the states of…Official notice → - 2022-01-05
- US
Intuitive Surgical, Inc. recalls da Vinci SP Surgical systems with the following Model Name/ Model Number / UDI: ASSY,PSS,SP1098,P4/ 380601-44/ 00886874114605…
Issue was identified during internal engineering evaluation. Use of the system with the affected software version may experience either an inability to deliver energy or an inadvertent delivery of energy. Use may…
FDA · DeviceIntuitive Surgical, Inc.US Nationwide distribution in the states of Arizona, California, Connecticut,…Official notice → - 2021-12-01
- US
Intuitive Surgical, Inc. recalls The da Vinci Xi and X surgical systems (IS4000 and IS4200) each consist of three main components: the Surgeon Console (SC), the Vision…
Incorrect expiration date on its package labeling (shipper box and inner carton label).
FDA · DeviceIntuitive Surgical, Inc.Worldwide distribution - U.S. Nationwide distribution in the states of AL, CA,…Official notice → - 2021-10-20
- US
Intuitive Surgical, Inc. recalls Ion Flexison Biopsy Needle, 19G, Extension Range : 0-3 cm, Ref: 490104-09 and 49004-10, 5-pack, Sterile EO, Rx only, UDI:00886874115978
Potential for the sheath tip on the biopsy needle to separate from the sheath shaft.
FDA · DeviceIntuitive Surgical, Inc.US: AZ, AR, CA, CO, DC, FL, GA, IL, IN, IO, MD, MA, MI, MN, MO, NV, NJ, NY,…Official notice →