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Intuitive Surgical, Inc.

Intuitive Surgical, Inc. Recalls

All product recalls associated with Intuitive Surgical, Inc..

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Recall Summary

Total Recalls

105

Past Year

Class I (Serious)

Most Recent

Feb 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 41–60 of 105 recalls

Intuitive Surgical, Inc.: Da Vinci X/Xi Large Clip Applier, Model 470230 Da Vinci X...

Due to the potential for unexpected motion caused by the partial disengagement of the instrument from the system.

FDAJul 1, 2022Nationwide• Intuitive Surgical, Inc.

Intuitive Surgical, Inc.: Da Vinci S/Si Large Clip Applier, Model 420230 Da Vinci S...

Due to the potential for unexpected motion caused by the partial disengagement of the instrument from the system.

FDAJul 1, 2022Nationwide• Intuitive Surgical, Inc.

Intuitive Surgical, Inc.: The E-100 Generator (PN 374848-09) is a bipolar electrosu...

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

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Jun 22, 2022

Nationwide

• Intuitive Surgical, Inc.

Intuitive Surgical, Inc.: da Vinici X da Vinci Xi Sureform 45 REF 480445 da Vinci...

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 Intuitives existing risk documentation.

FDAMar 17, 2022Nationwide• Intuitive Surgical, Inc.

Intuitive Surgical, Inc.: VESSEL SEALER EXTEND, Single-Use Instrument EndoWrist Ins...

Placing excessive tissue in the instrument jaws of the devices prior to sealing and transection can result in an insufficient seal.

FDAMar 3, 2022Nationwide• Intuitive Surgical, Inc.

Intuitive Surgical, Inc.: DAVINCI | Energy SynchroSeal da Vinci X' da Vinci Xi', Si...

Placing excessive tissue in the instrument jaws of the devices prior to sealing and transection can result in an insufficient seal.

FDAMar 3, 2022Nationwide• Intuitive Surgical, Inc.

Intuitive Surgical, Inc.: da Vinci Xi and X 12-8 mm Conductive Cannula Reducer, REF...

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.

FDADec 23, 2021Nationwide• Intuitive Surgical, Inc.

Intuitive Surgical, Inc.: da Vinci SP Surgical systems with the following Model Nam...

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.

FDASep 22, 2021Nationwide• Intuitive Surgical, Inc.

Intuitive Surgical, Inc.: The da Vinci Xi and X surgical systems (IS4000 and IS4200...

Incorrect expiration date on its package labeling (shipper box and inner carton label).

FDASep 21, 2021Nationwide• Intuitive Surgical, Inc.

Intuitive Surgical, Inc.: Ion Flexison Biopsy Needle, 19G, Extension Range : 0-3 cm...

Potential for the sheath tip on the biopsy needle to separate from the sheath shaft.

FDAAug 6, 2021AZ, AR, CA +23 more• Intuitive Surgical, Inc.

Intuitive Surgical, Inc.: Box Label: ION Fully Articulating Catheter, REF 490105, V...

The distal tip ring of the fully articulating catheter may become dislodged during the procedure.

FDAOct 23, 2020Nationwide• Intuitive Surgical, Inc.

Intuitive Surgical, Inc.: ION Reprocessing Accessories Kit, IF1000 (Part Number: 49...

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.

FDAJun 10, 2020CA, CO, FL +9 more• Intuitive Surgical, Inc.

Intuitive Surgical, Inc.: Ion Catheter Reprocessing Cover, IF1000 (Part Number:4901...

FDAJun 10, 2020CA, CO, FL +9 more• Intuitive Surgical, Inc.

Intuitive Surgical, Inc.: STAINLESS STEEL REPROCESSING TRAY, 8MM ENDOSCOPE, IS4000,...

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.

FDADec 19, 2019Nationwide• Intuitive Surgical, Inc.

Intuitive Surgical, Inc.: da Vinci SP Camera; PN 430060-33; Model Number: 430060-33...

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.

FDAAug 19, 2019Nationwide• Intuitive Surgical, Inc.

Intuitive Surgical, Inc.: da Vinci SP Surgical System, SP1098, 00886874114605 Prod...

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.

FDAJul 26, 2019Nationwide• Intuitive Surgical, Inc.

Intuitive Surgical, Inc.: da Vinci Xi Surgical System Surgical System, IS4000, 0088...

FDAJul 26, 2019Nationwide• Intuitive Surgical, Inc.

Intuitive Surgical, Inc.: da Vinci X Surgical System Surgical System, IS4200, 00886...

FDAJul 26, 2019Nationwide• Intuitive Surgical, Inc.

Intuitive Surgical, Inc.: daVinci XI Sureform 60 reload, 60 mm Green 6- Row, 4.6 mm...

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.

FDAJul 1, 2019Nationwide• Intuitive Surgical, Inc.

Intuitive Surgical, Inc.: da Vinci Surgical System, IS 4000; Endoscope Controller, ...

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.

FDAJun 17, 2019Nationwide• Intuitive Surgical, Inc.