Sunnyvale, CA, United States
Intuitive Surgical, Inc. recalls
53 recalls recorded since 2018, most recently on 24 April 2026. 35 are listed as ongoing. Status and classification are as published by the FDA.
Recalls53
Ongoing (FDA)35
Terminated or completed18
Class I (FDA)1
Ongoing Class II Medical devices
- Recall started
- 24 April 2026
- Reason
- 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 endoscope.
- Distribution
- U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NH, NJ, NM, NV, NY, NC, ND, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. O.U.S.: Australia, Belgium, France, Germany, Italy, Japan, Netherlands, New Zealand, Poland,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2310-2026
- Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746 Software Version: N/A Product Description: Preface: This report under 21 CFR 806.10 is being submitted for the dV5 system towe
Ongoing Class II Medical devices
- Recall started
- 22 April 2026
- Reason
- 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 motion. In addition, if it moves/backs out it may cause restricted column range of motion and/or uncontrolled motion, which may cause patient tissue injury/crushing injury/bleeding.
- Distribution
- Worldwide - US Nationwide distribution including in the states of CA, GA, OH, PA, NY, MN, TN, OR, IL, MD, NJ, AL, NV, TX, FL, LA, CT, NC, AZ, IA, MO, WA, MI, WV, WI, KY, KS, VA, OK, MA, IN, CO, SC, SD, MS, NH, UT, ME and the countries of Belgium, Denmark, Sweden, France, Japan, Germany, Israel, Swit
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2521-2026
- Da Vinci ASSY, PSS, SP1098, Part Number: 380601
Ongoing Class II Medical devices
- Recall started
- 2 April 2026
- Reason
- Due to manipulator containing screws with in the arm sub-assembly that my be susceptible to breaking.
- Distribution
- Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. The countries of Argentina, Au
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2046-2026
- Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X, Xi Surgical System Model/Catalog Number: IS4000; IS4200 Software Version: N/A Product Description: he da Vinci Xi, X Surgical systems each consist of
Ongoing Class I Medical devices
- Recall started
- 11 March 2026
- Reason
- Reloads for curved-tipped stapler may potentially produce an incomplete staple line.
- Distribution
- US: Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware District of Columbia Florida Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada New Hampshire New Jersey New Mex
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1855-2026
- Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06
Ongoing Class II Medical devices
- Recall started
- 30 December 2025
- Reason
- 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 displays-complete visualization loss, without fault, instruments remain active, could lead to instrument contact with tissue, resulting in injury/bleeding; may require alternate surgical modality.
- Distribution
- US Nationwide distribution in the states of KS, AZ, MA, FL, MI, NC, IL, DC, TX, KY, MS, CA, MN, NV, NY, WI, ID, GA, CT, SC, UT, VA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1355-2026
- da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Number: 380730-45
Ongoing Class II Medical devices
- Recall started
- 15 December 2025
- Reason
- Access Port System tray may develop cracks potentially resulting in a sterility breach.
- Distribution
- Worldwide - US Nationwide distribution including in the states of Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nevada, New Hampshire, New Jersey
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1096-2026
- da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 (2.7-4cm,SP1098, Box) & 430075 (2.7-7cm,SP1098,Box)
Ongoing Class II Medical devices
- Recall started
- 9 December 2025
- Reason
- Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments
- Distribution
- U.S. Nationwide distribution in the states of AR, CA, CT, FL, IA, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NJ, NM, NY, NC, OH, PA, TX, VA, and WA. The countries of Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Ecuador, Egypt, France, Germany, Greece, Gua
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1701-2026, Z-1700-2026
- Brand Name: da Vinci S, Si Permanent Cautery Hook Instrument Product Name: da Vinci S, Si Permanent Cautery Hook Instrument Model/Catalog Number: 420183 Software Version: NA Product Description: EndoWrist Instruments
- Brand Name: da Vinci S, Si Tenaculum Forceps Instrument Product Name: da Vinci S, Si Tenaculum Forceps Instrument Model/Catalog Number: 420207 Software Version: N/A Product Description: EndoWrist Instruments or Da Vi
Ongoing Class II Medical devices
- Recall started
- 9 December 2025
- Reason
- Due to increased complaints for broken/frayed grip cables for reusable instruments.
- Distribution
- Worldwide - U.S. Nationwide distribution in the states of CA, FL, GA, IA, IL, IN, KS, KY, LA, MA, MO, MS, NC, NJ, NY, OH, PA, TX, VA and WI. The countries of Argentina, Brazil, Canada, Chile, China, Cyprus, Czech Republic, Ecuador, France, Germany, Greece, Guadeloupe, India, Indonesia, Italy, Japan,
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1698-2026, Z-1699-2026, Z-1696-2026, Z-1697-2026
- Brand Name: da Vinci S, Si Mega Needle Driver Instrument Product Name: da Vinci S, Si Mega Needle Driver Instrument Model/Catalog Number: 420194 Software Version: NA Product Description: EndoWrist Instruments or Da V
- Brand Name: da Vinci S, Si Grasping Retractor Instrument Product Name: da Vinci S, Si Grasping Retractor Instrument Model/Catalog Number: 420278 Software Version: NA Product Description: EndoWrist Instruments or Da V
- Brand Name: da Vinci S, Si Monopolar Curved Scissors Instrument Product Name: da Vinci S and Si Monopolar Curved Scissors Instrument Model/Catalog Number: 420179 Software Version: N/A Product Description: EndoWrist I
- Brand Name: da Vinci S, Si Double Fenestrated Grasper Instrument Product Name: da Vinci S, Si Double Fenestrated Grasper Instrument Model/Catalog Number: 420189 Software Version: NA Product Description: EndoWrist Ins
Ongoing Class II Medical devices
- Recall started
- 4 December 2025
- Reason
- Due to probe bags that may have a compromised or incomplete sterile pouch seal.
- Distribution
- U.S.: AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MA, MD, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and WY. O.U.S.: Australia, China, France, Germany, Italy, Japan, South Korea, Spain, Switzerl
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1134-2026
- Brand Name: Ion Endoluminal System Product Name: Ion Vision Probe Bag Model/Catalog Number: 490127 Software Version: N/A Product Description: The Ion Endoluminal System is a robotically assisted platform for minimall
Ongoing Class II Medical devices
- Recall started
- 17 November 2025
- Reason
- 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.
- Distribution
- US distribution: LA, MA, NY, PA, TX, and VA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1428-2026
- Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used for minimally invasive surgery.
Ongoing Class II Medical devices
- Recall started
- 7 November 2025
- Reason
- 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 axis ball screws that exhibit the symptoms of being bent and misaligned which is a precursor to potential ball screw fatigue failure/fraction
- Distribution
- U.S.: AL, AR, CA, CO, CT, FL, ID, IL, IN, KS, KY, MD, MI, MN, MS, MO, NC, NJ, NV, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, and WI. O.U.S.: Austria, Brazil, China, France, Germany, Greece, India, Italy, Japan, Lebanon, Netherlands, South Korea, Spain, Switzerland, Taiwan and United Kingdom
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1232-2026
- Brand Name: Da Vinci Product Name: da Vinci X, Xi Surgical System, & da Vinci 5 Surgical System Model/Catalog Number: IS4000; IS4200; IS5000 Software Version: N/A Product Description: The da Vinci Xi, X, and da Vinc
Ongoing Class II Medical devices
- Recall started
- 12 May 2025
- Reason
- 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 in procedure delay or conversion to an alternate minimally invasive approach. Retrospectively reported recall.
- Distribution
- Worldwide - US Nationwide distribution in the states of NJ, OR, NY, FL, AL, SD, TX, VA, WV, PA, CA, WA, CT, MA, IL, OK, OH, MI, NC, MO, KY, WI, AZ, CO, GA, MD, SC, IN, NV, TN, MS, KS, IA, UT, MN, LA, NE, ME and the countries of Germany, Sweden, United Kingdom, Italy, Belgium, Switzerland, Denmark, J
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2722-2026
- da Vinci SP Instrument Arm Drape, SP, 1-PACK, Part Number: 430013-13, 430013-15
Ongoing Class II Medical devices
- Recall started
- 26 February 2025
- Reason
- Due to an increase in complaints concerning foot tray pedal spring failing resulting in the pedal remaining pressed
- Distribution
- Worldwide distribution - US Nationwide and the countries of Alaska, Arizona, Arkansas, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebra
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1325-2025
- Brand Name: Da Vinci 5 Product Name: ASSY,DV5 CONSOLE,IS5000 Foot Tray Pedals Model/Catalog Number: 380730 Software Version: N/A . Refer to HHE for additional details. Component: N/A
Ongoing Class II Medical devices
- Recall started
- 19 December 2024
- Reason
- Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- Distribution
- U.S. - Nation-wide. Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebra
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0870-2025, Z-0880-2025, Z-0849-2025, Z-0874-2025, Z-0847-2025, Z-0862-2025, Z-0859-2025, Z-0872-2025, Z-0851-2025, Z-0857-2025, Z-0858-2025, Z-0873-2025 and 25 more
- 8MM,HORIZON SMALL CLIP APPLIER,IS4000¿ REF 470401
- 8MM,MEGA SUTURECUT ND,IS4000 REF 471309
- 8MM, LARGE NEEDLE DRIVER, IS4000 REF 470006
- 8MM,PROGRASP FORCEPS,IS4000 REF 471093
- 8MM, MONOPOLAR CURVED SCISSORS, IS4000 REF 470179
- 8MM,ATRIAL RETRACTOR SHORT RIGHT,IS4000¿ REF 470246
- 8MM,FENESTRATED BIPOLAR FORCEPS,IS4000¿ REF 470205
- 8MM,LONG TIP FORCEPS,IS4000 REF 471048
- and 29 more product lines
Ongoing Class II Medical devices
- Recall started
- 19 December 2024
- Reason
- Due to an increase in complaints for pitch cable failures related to forceps and small Graptor instruments
- Distribution
- U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MS, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WV, WI, and WY. The countries of Canada
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0924-2025, Z-0923-2025
- 8MM, Small Graptor REF 470318 Is a grasping retractor Instrument used with the da Vinci X/Xi Surgical Systems in a wide variety of procedures to perform a variety of surgical tasks including manipulation and retractio
- 8MM, Tenaculum Forceps REF 470207 Instrument used with the da Vinci X/Xi Surgical Systems in a wide variety of procedures to perform a variety of surgical tasks including manipulation and retraction of tissue.
Ongoing Class II Medical devices
- Recall started
- 21 August 2024
- Reason
- 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 adjusted until da Vinci is restarted. Contact Technical Support to report the issue: Cancel-Disable" ergonomics locked until motor replaced; may lead to delay/aborted/alternate procedure
- Distribution
- US Nationwide distribution in the states of MN, FL, CO, CA, NC, KS, TX, SC, WV, LA, OH, NY, NH, GA, KY, OK, NJ, MA, OR, PA, NM, AZ, TN, ND, IL, AR, WA, IN, VA, CT.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0964-2026
- da Vinci 5, Surgeon Console Column Motor Connector; ASSY,DV5 CONSOLE,SSC,IS5000; Part Number: 380730-40
Ongoing Class II Medical devices
- Recall started
- 12 July 2024
- Reason
- 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.
- Distribution
- US Nationwide distribution in the states of AZ and CA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2720-2024
- Ion Endoluminal System, REF: 380748-65
Ongoing Class II Medical devices
- Recall started
- 13 March 2024
- Reason
- 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.
- Distribution
- US: VA, CA, NH, FL, NY, CO, AL, KY, MD, NC, NJ, OH, SC, SD, TN, WA, WI, WV, MS, TX, KS. OUS: China, France, Japan, South Korea
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1518-2024
- Patient Cart, Part: 380601, a component of the da Vinci SP Surgical System, Model: SP1098
Ongoing Class II Medical devices
- Recall started
- 6 October 2023
- Reason
- There is the potential for the needle drive to become dislodged and/or broken which could result in uncontrollable movement.
- Distribution
- US: IL, FL, ID, SC, MI, TX, TN, NY, OR, CO, CA, MS, NJ, Puerto Rico OUS: South Korea
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0406-2024
- Da Vinci Single-Site Wristed Needle Driver, REF: 478115, 5 mm
Ongoing Class II Medical devices
- Recall started
- 12 June 2023
- Reason
- 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.
- Distribution
- Worldwide - US Nationwide distribution in the states of PR, FL, MN, PA, AZ, OH, IL, NC, GA, KS, CA, HI, MD, OR, SC, AK, NY, NE, IA, WA, OK, ND, UT, MS, AR, WI, MI, TX, TN, IN, NJ, VA, SD, CO, KY, AL, MO, LA, DE, MA, MT, WV, ID, CT, NV, NH, ME, WY, DC, RI, NM, VT and the countries of Australia, Austr
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2059-2023
- da Vinci Xi/X Tip-Up Fenestrated Grasper, REF: 470347, VER: 12
Ongoing Class II Medical devices
- Recall started
- 10 February 2023
- Reason
- Due to Universal Surgical Manipulator (USM) instrument carriage being loose as a result of the linear rail component not being manufactured within specifications.
- Distribution
- U.S.: Cayman Islands, Dominican Republic, Puerto Rico, United States O.U.S.: Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Luxembourg, Martinique, Monaco, Netherlands, Norway, Reunion, Sweden, Switzerland, United Kingdom, India, Japan, South Korea, Taiwan, Brazil, Argentina, Austral
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1293-2023
- da Vinci Xi Surgical System Model IS4000 da Vinci X Surgical System Model IS4200
Ongoing Class II Medical devices
- Recall started
- 24 January 2023
- Reason
- 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.
- Distribution
- Worldwide - US Nationwide distribution in the states of FL, GA, WA and the countries of United Kingdom, Germany, France
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1262-2023
- Patient 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,
Ongoing Class II Medical devices
- Recall started
- 7 October 2022
- Reason
- Potential staple deployment failure and device fragment generation
- Distribution
- U.S.: Arizona, California, Colorado, Florida, Illinois, Indiana, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Nevada, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, and Wisconsin. O.U.S.: None
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0340-2023
- 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 4-Row 2.0 mm Xi|X REF 48230M INTUITIVE Da Vinci 8mm SureForm 30 Reload 30 mm W
Ongoing Class II Medical devices
- Recall started
- 20 September 2022
- Reason
- 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) Yellow pedal associated with force bipolar is pressed, released with head in surgeon console 4) Blue pedal associated with bipolar is pressed, resulting in force bipolar energy delivery
- Distribution
- US: MS, PA, WI, KY, TN, MI, FL, GA, NC, NV, LA, OH, IL, MO, IN, CA, AK, MD, TX, IA, MA, NE, AZ, WA, CO, AL, SC
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0133-2023
- da Vinci X (IS4200) and Xi (IS4000) systems, which consists of finished devices Surgeon Console (SSC), Patient Cart (PSCART), Vision System (VSS)
Ongoing Class II Medical devices
- Recall started
- 1 July 2022
- Reason
- Due to the potential for unexpected motion caused by the partial disengagement of the instrument from the system.
- Distribution
- Worldwide distribution - U.S. Nationwide distribution in the states of AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and WY. The coun
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1459-2022, Z-1460-2022
- 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, Model 420003
- Da Vinci X/Xi Large Clip Applier, Model 470230 Da Vinci X/Xi Medium-Large Clip Applier, Model 470327 Da Vinci X/Xi Small Clip Applier, Model 47401
Completed Class II Medical devices
- Recall started
- 22 June 2022
- Reason
- 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.
- Distribution
- Worldwide distribution - U.S. Nationwide distribution in the states of AL, AK, AZ, AR, CA, CO, CT, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV, WI, and WY. The countries of Belgium, Denmark, Germany,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1484-2022
- 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 E-100 is installed on the Vision Cart and is connected to the system. The functions o
Ongoing Class II Medical devices
- Recall started
- 17 March 2022
- Reason
- 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. Overall rate of harm associated with bleeding of critical severity exceeds the predicted likelihood of harm as documented within Intuitive s existing risk documentation.
- Distribution
- Worldwide distribution - U.S. Nationwide distribution in the states of AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and WY. The coun
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0999-2022
- 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 60 REF 480460
Completed Class II Medical devices
- Recall started
- 3 March 2022
- Reason
- Placing excessive tissue in the instrument jaws of the devices prior to sealing and transection can result in an insufficient seal.
- Distribution
- Worldwide distribution - US Nationwide and the countries/regions of Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Cyprus, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Greece, Guadeloupe, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Leb
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1209-2022, Z-1210-2022
- VESSEL SEALER EXTEND, Single-Use Instrument EndoWrist Instruments 8mm, da Vinci X' da Vinci Xi', REF 480422
- DAVINCI | Energy SynchroSeal da Vinci X' da Vinci Xi', Single Use Instrument 8mm, REF 480440
Ongoing Class II Medical devices
- Recall started
- 23 December 2021
- Reason
- 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 potential for energy leakage, which could cause tissue damage. If the metal tip remains in the patient, adhesions may form, which may lead to bowel obstruction and chronic abdominal pain.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of California, Wisconsin, Virginia, Ohio, Texas, New York, Nevada, Connecticut, New Jersey, Massachusetts, Georgia, Florida, Indiana, North Carolina, Missouri, Pennsylvania, Michigan, Oregon, Kentucky, Hawaii, Tennessee, Alabama, Nebr
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0702-2022
- da Vinci Xi and X 12-8 mm Conductive Cannula Reducer, REF: 470381-11
Ongoing Class II Medical devices
- Recall started
- 22 September 2021
- Reason
- 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 require surgeon to resolve an injury or need moderate intraoperative intervention. Also, use may potentially cause user frustration or a minor delay to troubleshoot.
- Distribution
- US Nationwide distribution in the states of Arizona, California, Connecticut, Florida, Illinois, Kansas, Kentucky, Massachusetts, Minnesota, Missouri, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Virginia, Washington, and Wisconsin.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0419-2022
- da Vinci SP Surgical systems with the following Model Name/ Model Number / UDI: ASSY,PSS,SP1098,P4/ 380601-44/ 00886874114605 ASSY,SSC,SP1098,P4/ 380940-44 / 00886874114735 ASSY,VSS,SP1098,P4/ 380941-44 / 00886874114742
Terminated Class II Medical devices
- Recall started
- 21 September 2021
- Terminated
- 25 January 2024
- Reason
- Incorrect expiration date on its package labeling (shipper box and inner carton label).
- Distribution
- Worldwide distribution - U.S. Nationwide distribution in the states of AL, CA, GA, IL, FL, CO, TX, MO, OH, MA, WI, NC, LA, UT and the country of South Korea.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0275-2022
- The da Vinci Xi and X surgical systems (IS4000 and IS4200) each consist of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The Patient Cart is the operative component of
Terminated Class II Medical devices
- Recall started
- 6 August 2021
- Terminated
- 17 May 2024
- Reason
- Potential for the sheath tip on the biopsy needle to separate from the sheath shaft.
- Distribution
- US: AZ, AR, CA, CO, DC, FL, GA, IL, IN, IO, MD, MA, MI, MN, MO, NV, NJ, NY, NC, OH, OK, PA, TN, TX, UT, VA, WA OUS: China
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0106-2022
- Ion Flexison Biopsy Needle, 19G, Extension Range : 0-3 cm, Ref: 490104-09 and 49004-10, 5-pack, Sterile EO, Rx only, UDI:00886874115978
Terminated Class II Medical devices
- Recall started
- 23 October 2020
- Terminated
- 5 December 2022
- Reason
- The distal tip ring of the fully articulating catheter may become dislodged during the procedure.
- Distribution
- US Nationwide distribution including in the states of CA, CO, DC, FL, IA, IL, MA, MD, MI, MN, NC, NJ, NY, OH, PA, TX, UT, and VA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0489-2021
- Box Label: ION Fully Articulating Catheter, REF 490105, VER 08 - Product Usage: used to navigate the Ion Fully Articulating Catheter within the lung to a planned path in order to sample a target. User Manual: ION End
Ongoing Class II Medical devices
- Recall started
- 10 June 2020
- Reason
- One type of the ION Catheter Reprocessing Covers (PN 490114-02) has the potential to become disengaged or incorrectly engaged to the ION Fully Articulating Catheter which can result in retention of cleaning chemical or water during reprocessing; may cause failure of the ION Fully Articulating Catheter or ION System.
- Distribution
- U.S.: California, Colorado, Florida, Illinois, Massachusetts, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Texas, and Virginia. No foreign consignees.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2949-2020, Z-2950-2020
- Ion Catheter Reprocessing Cover, IF1000 (Part Number:490114-02) UDI:00886874116845.
- ION Reprocessing Accessories Kit, IF1000 (Part Number: 490024-03) UDI:00886874119129. The kit includes an ION Catheter Reprocessing Cover (Part Number: 490114-02).
Terminated Class II Medical devices
- Recall started
- 19 December 2019
- Terminated
- 31 August 2023
- Reason
- Small but detectable holes in the sterilization wrap used with the firm's 8 mm endoscope sterilization trays and handheld camera sterilization trays could lead to a potential breach of sterility and risk of infection. Certain features on the trays with handling and storage may cause these holes.
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of Arkansas, Arizona, Alabama, Alaska, California, Connecticut, Colorado, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Idaho, Kentucky, Kansas, Louisiana, Missouri, Michigan, Maryland, Mississippi, Minnesota, Montana,
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2328-2020, Z-2329-2020
- STAINLESS STEEL REPROCESSING TRAY, 8MM ENDOSCOPE, IS4000, Model No. 400498-02 - Product Usage: is designed to enable complex surgery using a minimally invasive approach.
- STAINLESS STEEL REPROCESSING TRAY, 2D CAMERA HEAD, IS4000, Model No. 400499-03 - Product Usage: is designed to enable complex surgery using a minimally invasive approach.
Ongoing Class II Medical devices
- Recall started
- 19 August 2019
- Reason
- Some cameras were found to have residual soil adhered to the tip of the camera after reprocessing which may affect image quality resulting in needing to switch to a second camera or converting to another surgical modality. If residual soil makes contact with the patient, exposure could result in sensitization making future component blood therapy or tissue typing more challenging; additionally if a small piece of inert epoxy were to be retained, scar tissue could form.
- Distribution
- Distribution US nationwide and South Korea.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2131-2020
- da Vinci SP Camera; PN 430060-33; Model Number: 430060-33. For endoscopic surgery.
Terminated Class II Medical devices
- Recall started
- 26 July 2019
- Terminated
- 10 August 2022
- Reason
- The firm become aware of a potentially defective capacitors on circuit boards installed on certain da Vinci Xi, X and SP system Vision Side Carts (VSC) and/or Patient Side Carts (PSC). As a result, you may experience either vision loss or non-recoverable errors 307 or 319, preventing further use of the system.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of Alabama, Alaska, Arizona, California, Colorado, Connecticut, Florida, Hawaii, Idaho, Illinois, Iowa, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Montana, New Jersey, New Mexico, New York, North Caroli
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0926-2020, Z-0925-2020, Z-0927-2020
- da Vinci X Surgical System Surgical System, IS4200, 00886874114216 Product Usage: used with an endoscope, surgical instruments, and accessories to perform minimally invasive surgical procedures.
- da Vinci Xi Surgical System Surgical System, IS4000, 00886874114216 - Product Usage: used with an endoscope, surgical instruments, and accessories to perform minimally invasive surgical procedures.
- da Vinci SP Surgical System, SP1098, 00886874114605 Product Usage: used with an endoscope, surgical instruments, and accessories to perform minimally invasive surgical procedures.
Ongoing Class II Medical devices
- Recall started
- 1 July 2019
- Reason
- The firm became aware of a manufacturing variation in which black and green reloads in select Stapler Reloads may not deploy individual adjacent staples, which could result in an incomplete staple line. Failure of a incomplete staple like could potentially lead to an air leak or an anastomotic leak which may require an additional procedural intervention.
- Distribution
- Worldwide distribution - US Nationwide including in the states of AL, AK, AZ, AR, CA, CO, CT, DE, D.C., FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WV, WI and the countries of Australia, Czech Republic, Denma
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1891-2020, Z-1890-2020
- daVinci XI Sureform 60 Reload, 60 mm black 6-Row 4.6 mm, Ref: 48360T-08 , UDI: 00886874113851, Rx only, SterileEO - Product Usage: are intended to be used with da Vinci Surgical Systems for resection, transection, and,
- daVinci XI Sureform 60 reload, 60 mm Green 6- Row, 4.6 mm, REF 48360G-08, UDI: 00886874113844, Rx Only, Sterile EO - Product Usage: are intended to be used with da Vinci Surgical Systems for resection, transection, and,
Terminated Class II Medical devices
- Recall started
- 17 June 2019
- Terminated
- 18 July 2022
- Reason
- One da Vinci Xi Endoscope Controller in the field was improperly calibrated during servicing. The result of this improper calibration may result in the tip of the endoscope may reach higher temperature causing the potential for thermal tissue injury and/or overly bright images.
- Distribution
- US Nationwide distribution including in the state of Washington.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0283-2021
- da Vinci Surgical System, IS 4000; Endoscope Controller, Model Number: 372601-16 (UDI: 00886874114193) is included in the IS 4000 Vision Cart, Model Number: 381121-31 (UDI 00886874110898) - Product Usage: used with an en
Terminated Class II Medical devices
- Recall started
- 11 April 2019
- Terminated
- 8 April 2024
- Reason
- Failure of Universal Surgical Manipulators due to a high friction points, resulting in an increase of arm movement to include: feelings of resistance, hesitation, and jerking.
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of AK, AZ, CA, CO, CT, District of Columbia, FL, GA, IL, IN, IA, KS. MA, MI, MS, NB, NY, OH, PA, TN, TX, VA, WA and WI and the countries of Australia, Belgium, Brazil, France, Germany, India, Italy, Japan, South Korea, Spain
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1897-2020, Z-1896-2020
- da Vinci X Surgical System, IS4200 - Product Usage: The da Vinci Xi surgical system (IS4000) is made of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The Patient Cart i
- da Vinci Xi Surgical System, IS4000 - Product Usage: The da Vinci Xi surgical system (IS4000) is made of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The Patient Cart
Terminated Class II Medical devices
- Recall started
- 1 April 2019
- Terminated
- 16 December 2021
- Reason
- Intuitive has become aware that the da Vinci SP system may trigger a mechanical vibration of the instrument tips and endoscope due to a software anomaly. This issue has the potential to occur only under the following, extremely rare specific conditions: 1) the user is activating Adjust Mode, AND 2) the instrument Arm is near its vertical position limit, AND 3) the user is applying sustained force against the hand control haptic feedback.
- Distribution
- U.S.: OH, PN, NY, MN, TN, TX, OR, IL, MD, NJ, AL. O.U.S.: South Korea
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2260-2020
- da Vinci SP surgical system
Ongoing Class II Medical devices
- Recall started
- 16 January 2019
- Reason
- During an internal inspection, Intuitive found that the sterile packaging of the da Vinci S/Si Harmonic ACE Inserts may become damaged during transit. The potential damage includes pinholes and /or small openings (less than a few millimeters) on the pouch leading to a potential breach in sterility.
- Distribution
- US and Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, Finland, France, Germany, India, Israel, Italy, Japan, Kuwait, Lebanon, Mexico, Monaco, Netherlands, Pakistan, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, South Korea, Spain, Taiwan, Turkey, United
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0841-2019
- daVinci Harmonic ACE Curved Shears
Terminated Class II Medical devices
- Recall started
- 4 December 2018
- Terminated
- 24 August 2022
- Reason
- This recall is being initiated because lots of EndoWrist Monopolar Curved Scissor instruments are not recognized by the integrated electrosurgical unit, which prohibits the activation of monopolar energy from the surgeon console.
- Distribution
- US National Distribution Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Illinois, Indiana, Iowa, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New York, No
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1105-2020
- Da Vinci Xi/X EndoWrist Monopolar Curved scissors (MCS), model number 470179-19, UDI: (00) 886874112298
Terminated Class II Medical devices
- Recall started
- 21 November 2018
- Terminated
- 31 May 2022
- Reason
- Due to a manufacturing variation in the arm that can result in a persistent recoverable fault error (error 23087) and loss of arm functionality prior or during surgery.
- Distribution
- U.S.: CA, MD, NY, VA, IL, MI, DE, TX, FL, NJ, MA, KY and OH. O.U.S.: Australia, France, Germany and Japan.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1960-2020, Z-1961-2020
- da Vinci Xi Surgical System
- da Vinci X Surgical System
Terminated Class II Medical devices
- Recall started
- 25 October 2018
- Terminated
- 5 April 2024
- Reason
- The instrument drape may tear while draping the Patient Side Cart presenting a breach in the sterile barrier.
- Distribution
- Updated information provided on 03/18/2020: FL, OH, TN, NJ, PA, MD, NY, CA, MN, NV, OR, HI, VA, TX, AL, CA, IL, CN, and NC. OUS: APAC (Asia Pacific) - South Korea
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1906-2020
- da Vinci SP Instrument Arm Drape. REF 430013-12 QTY 1 Pouch
Terminated Class II Medical devices
- Recall started
- 23 October 2018
- Terminated
- 21 January 2022
- Reason
- The firm became aware of a problem with the surgical system where the cannula mount button may be damaged when the user releases the button abruptly.
- Distribution
- Product distributed in the US to the following states: Minnesota, New York, Ohio, and Pennsylvania.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0845-2020
- The da Vinci SP surgical system is made of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The Patient Cart is the operative component of the SP system and its primary fu
Ongoing Class II Medical devices
- Recall started
- 15 August 2018
- Reason
- Monopolar Curved Scissor (MCS) instruments may be susceptible to developing cracks near the proximal edge of the extension tube. These cracks may fracture the plastic surrounding the instrument shaft, and may cause fragments of the extension tube to fall, including potentially into the patient.
- Distribution
- Worldwide Distribution - US Nationwide in the states of : AL, AK, AZ, AR, CA, CO, CT, DC, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, MA, ME, MD, MI, MN, MS, MO, NB, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WV, WI, and WY and the countries of : Argentina, Aus
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-3024-2018, Z-3025-2018
- da Vinci S/Si EndoWrist 8mm Monopolar Curved Scissors Model No. 420179-16 Product Usage: EndoWrist Instruments, including scissors, scalpels, forceps, needle drivers and electrocautery are intended for endoscopic man
- da Vinci X/Xi EndoWrist 8mm Monopolar Curved Scissors Model No. 470179-14 Product Usage: EndoWrist Instruments, including scissors, scalpels, forceps, needle drivers and electrocautery are intended for endoscopic man
Terminated Class II Medical devices
- Recall started
- 16 July 2018
- Terminated
- 5 October 2023
- Reason
- Certain Redundant Medical Grade Power Supply (RMGPS) units specific to Surgeon Console and Patient Side Carts were manufactured incorrectly and may fail prior or during use.
- Distribution
- Worldwide Distribution: US (nationwide) and countries of: Austria, Australia, Belgium, Brazil, Canada, Switzerland, China, Czech Republic, Germany, Denmark, Ecuador, Spain, Finland, France, United Kingdom, Greece, Hong Kong, Ireland, Israel, India, Italy, Japan, Korea, Kuwait, Luxembourg, Mexico, Ne
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3254-2018
- da Vinci Si/X/Xi Surgical System Redundant Medical Grade Power Supply (RMGPS) Units The da Vinci System consists of a Surgeon Console, a Patient Cart, and a Vision Cart and is used with an endoscope, da Vinci EndoWri
Ongoing Class II Medical devices
- Recall started
- 4 June 2018
- Reason
- The firm has identified the potential for a silicone particle to be generated within the Suction Irrigator device. If generated, a particle may be introduced into the patient with irrigation.
- Distribution
- Worldwide distribution. US nationwide, Australia, Italy, Switzerland, and United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0249-2020
- EndoWrist Suction Irrigator, Single Use Instrument. Part Number: 480299-04. An accessory to the EndoWrist Surgical System, used in endoscopic surgery.
Ongoing Class II Medical devices
- Recall started
- 17 May 2018
- Reason
- An Endoscope Controller has been improperly calibrated during manufacturing. This improper calibration may result in the Endoscope Controller showing surgical images that are dimmer, have color imbalance or have reduced fluorescence and grayscale when using Firefly. There is also potential for increased fogging of the endoscope.
- Distribution
- U.S.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2835-2018
- The da Vinci Xi Surgical System (IS4000) Model Name: IS4000, Endoscope Controller. Model Number: 372601-16.
Terminated Class II Medical devices
- Recall started
- 23 April 2018
- Terminated
- 15 July 2020
- Reason
- Intuitive Surgical, Inc. (ISI) has recently become aware of an issue with the da Vinci Xi Stapler 45 Blue and Green Reloads that may be missing a component of the knife mechanism. Without this component, the reload knife will not move and cut tissue when the stapler is fired.
- Distribution
- U.S., foreign and government accounts. Foreign: Australia, Austria, Belgium, Brazil, Canada, China (Hong Kong), Czech Republic, Denmark, Finland, France, Germany, Ireland, Italy, Japan, Luxembourg, Netherlands, Norway, Qatar, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan,
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2381-2018, Z-2380-2018
- da Vinci Xi EndoWrist Stapler 45 Reload Green, Model 48445G-03, 12 reloads/box.
- da Vinci Xi EndoWrist Stapler 45 Reload Blue, Model 48645B-03, 12 reloads/box.
Terminated Class II Medical devices
- Recall started
- 7 March 2018
- Terminated
- 29 July 2020
- Reason
- Specific da Vinci X Surgical Systems (IS4200) were shipped with defective Arm Controller Joint (ACJ) boards that were found to have a high rate of failure due to a defective component.
- Distribution
- US Nationwide AR, CA, FL, GA, IL, IA, MN, MS, NE, OK, TN, and TX. Foreign distribution was made to Australia, Austria, Finland, France, Germany, Italy, Netherlands, Spain, and United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2341-2018
- da Vinci X Surgical System, Model IS4200. Product Usage: The Intuitive Surgical Endoscopic Instrument Control System (da Vinci X Surgical System Mode IS4200) is intended to assist in the accurate control of Intuitive
Terminated Class II Medical devices
- Recall started
- 19 September 2017
- Terminated
- 30 January 2024
- Reason
- Specific da Vinci Xi EndoWrist Stapler 45 instruments are potentially impacted by a variation in the manufacturing process. In affected instruments, there is a possibility that the Stapler Release Kit (SRK) Wrench interface feature accessed through release hole 2 is manufactured to an incorrect dimension, which may prevent the SRK Wrench from being able to manually unclamp the instrument.
- Distribution
- US Nationwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0404-2018
- daVinci X EndoWrist(R) Stapler 45, REF 470298 Product Usage: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads, and other Stapler Accessories (including the bladeless obturators) are intended to be used
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.