Recall archive
90 recalls · page 2 of 4
Reported May 4, 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…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intuitive Surgical, Inc.
Matched: Brand · Reason for recall — As a result of complaint data review, it identified tissue pushout events occurring during firing of the SureForm stapler when tissue is pushed…
FDA (openFDA device enforcement)
Reported Mar 9, 2022
da Vinci Xi and X 12-8 mm Conductive Cannula Reducer, REF: 470381-11
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intuitive Surgical, Inc.
Matched: Brand — Conductive Cannula Reducer metal tip may get dislodged from the plastic shaft. If unnoticed, additional surgery may be required to remove the metal…
FDA (openFDA device enforcement)
Reported Jan 5, 2022
da Vinci SP Surgical systems with the following Model Name/ Model Number / UDI: ASSY,PSS,SP1098,P4/ 380601-44/…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intuitive Surgical, Inc.
Matched: Brand · Product · Product details — Issue was identified during internal engineering evaluation. Use of the system with the affected software version may experience either an inability…
FDA (openFDA device enforcement)
Reported Dec 1, 2021
The da Vinci Xi and X surgical systems (IS4000 and IS4200) each consist of three main components: the Surgeon Console…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intuitive Surgical, Inc.
Matched: Brand · Product · Product details — Incorrect expiration date on its package labeling (shipper box and inner carton label).
FDA (openFDA device enforcement)
Reported Oct 20, 2021
Ion Flexison Biopsy Needle, 19G, Extension Range : 0-3 cm, Ref: 490104-09 and 49004-10, 5-pack, Sterile EO, Rx only,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intuitive Surgical, Inc.
Matched: Brand — Potential for the sheath tip on the biopsy needle to separate from the sheath shaft.
FDA (openFDA device enforcement)
Reported Dec 2, 2020
Box Label: ION Fully Articulating Catheter, REF 490105, VER 08 - Product Usage: used to navigate the Ion Fully…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intuitive Surgical, Inc.
Matched: Brand — The distal tip ring of the fully articulating catheter may become dislodged during the procedure.
FDA (openFDA device enforcement)
Reported Nov 4, 2020
da Vinci Surgical System, IS 4000; Endoscope Controller, Model Number: 372601-16 (UDI: 00886874114193) is included in…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intuitive Surgical, Inc.
Matched: Brand · Product · Product details — One da Vinci Xi Endoscope Controller in the field was improperly calibrated during servicing. The result of this improper calibration may result in…
FDA (openFDA device enforcement)
Reported Sep 16, 2020
Ion Catheter Reprocessing Cover, IF1000 (Part Number:490114-02) UDI:00886874116845.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intuitive Surgical, Inc.
Matched: Brand — One type of the ION Catheter Reprocessing Covers (PN 490114-02) has the potential to become disengaged or incorrectly engaged to the ION Fully…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 17, 2020
STAINLESS STEEL REPROCESSING TRAY, 8MM ENDOSCOPE, IS4000, Model No. 400498-02 - Product Usage: is designed to enable…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intuitive Surgical, Inc.
Matched: Brand — Small but detectable holes in the sterilization wrap used with the firm's 8 mm endoscope sterilization trays and handheld camera sterilization trays…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 10, 2020
da Vinci SP surgical system
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intuitive Surgical, Inc.
Matched: Brand · Product · Product details · Reason for recall — 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…
FDA (openFDA device enforcement)
Reported Jun 3, 2020
da Vinci SP Camera; PN 430060-33; Model Number: 430060-33. For endoscopic surgery.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intuitive Surgical, Inc.
Matched: Brand · Reason for recall — 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…
FDA (openFDA device enforcement)
Reported May 20, 2020
da Vinci Xi Surgical System
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intuitive Surgical, Inc.
Matched: Brand · Product · Product details — 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…
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 13, 2020
daVinci XI Sureform 60 reload, 60 mm Green 6- Row, 4.6 mm, REF 48360G-08, UDI: 00886874113844, Rx Only, Sterile EO -…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intuitive Surgical, Inc.
Matched: Brand · Product details — The firm became aware of a manufacturing variation in which black and green reloads in select Stapler Reloads may not deploy individual adjacent…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 12, 2020
da Vinci Xi Surgical System Surgical System, IS4000, 00886874114216 - Product Usage: used with an endoscope, surgical…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intuitive Surgical, Inc.
Matched: Brand · Product · Product details — 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…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 5, 2020
The da Vinci SP surgical system is made of three main components: the Surgeon Console (SC), the Vision Cart (VC), and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intuitive Surgical, Inc.
Matched: Brand · Product · Product details · Reason for recall — 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.
FDA (openFDA device enforcement)
Reported Nov 6, 2019
EndoWrist Suction Irrigator, Single Use Instrument. Part Number: 480299-04. An accessory to the EndoWrist Surgical…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intuitive Surgical, Inc.
Matched: Brand · Product · Product details — The firm has identified the potential for a silicone particle to be generated within the Suction Irrigator device. If generated, a particle may be…
FDA (openFDA device enforcement)
Reported Feb 27, 2019
daVinci Harmonic ACE Curved Shears
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intuitive Surgical, Inc.
Matched: Brand · Reason for recall — During an internal inspection, Intuitive found that the sterile packaging of the da Vinci S/Si Harmonic ACE Inserts may become damaged during…
FDA (openFDA device enforcement)
Reported Oct 3, 2018
da Vinci Si/X/Xi Surgical System Redundant Medical Grade Power Supply (RMGPS) Units The da Vinci System consists of a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intuitive Surgical, Inc.
Matched: Brand · Product · Product details — Certain Redundant Medical Grade Power Supply (RMGPS) units specific to Surgeon Console and Patient Side Carts were manufactured incorrectly and may…
FDA (openFDA device enforcement)
Reported Sep 19, 2018
da Vinci S/Si EndoWrist 8mm Monopolar Curved Scissors Model No. 420179-16 Product Usage: EndoWrist Instruments,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intuitive Surgical, Inc.
Matched: Brand · Product details — Monopolar Curved Scissor (MCS) instruments may be susceptible to developing cracks near the proximal edge of the extension tube. These cracks may…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 22, 2018
The da Vinci Xi Surgical System (IS4000) Model Name: IS4000, Endoscope Controller. Model Number: 372601-16.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intuitive Surgical, Inc.
Matched: Brand · Product · Product details · Reason for recall — An Endoscope Controller has been improperly calibrated during manufacturing. This improper calibration may result in the Endoscope Controller showing…
FDA (openFDA device enforcement)
Reported Jul 18, 2018
da Vinci Xi EndoWrist Stapler 45 Reload Blue, Model 48645B-03, 12 reloads/box.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intuitive Surgical, Inc.
Matched: Brand · Reason for recall — 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…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 11, 2018
da Vinci X Surgical System, Model IS4200. Product Usage: The Intuitive Surgical Endoscopic Instrument Control System…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intuitive Surgical, Inc.
Matched: Brand · Product · Product details · Reason for recall — 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…
FDA (openFDA device enforcement)
Reported Jan 31, 2018
daVinci X EndoWrist(R) Stapler 45, REF 470298 Product Usage: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intuitive Surgical, Inc.
Matched: Brand · Product · Product details — Specific da Vinci Xi EndoWrist Stapler 45 instruments are potentially impacted by a variation in the manufacturing process. In affected instruments,…
FDA (openFDA device enforcement)
Reported Jul 5, 2017
da Vinci Xi Surgical System Product Usage: The da Vinci Xi Surgical System (IS4000) is designed to assist a surgeon in…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intuitive Surgical, Inc.
Matched: Brand · Product · Product details · Reason for recall — da Vinci Xi(R) Surgical System Patient Side Carts (PSC) were shipped to the field with potentially under-torqued brake screws in a section of the…
FDA (openFDA device enforcement)
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