Recall archive
90 recalls · page 4 of 4
Reported Oct 22, 2014
EndoWrist One Vessel Sealer used in conjunction with the da Vinci Si Surgical System IS3000. The Endo Wrist One Vessel…
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 Surgical is initiating a voluntary correction relating to the labeling and software associated with the EndoWrist. One Vessel Sealer for…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 8, 2014
ASSEMBLY, PATIENT SIDE CART, PS4000 used with the da Vinci Xi Surgical System. Product Usage: The Intuitive Surgical…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intuitive Surgical, Inc.
Matched: Brand · Product · Product details · Reason for recall — Correction due to the detection of a motor sensor failure in the Patient Cart instrument arms of the da Vinci Xi (IS4000) Surgical Systems after a…
FDA (openFDA device enforcement)
Reported Aug 20, 2014
EndoWrist Stapler System User Manual Addendum and Wall Chart; The EndoWrist Stapler 45 System and EndoWrist Stapler 45…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intuitive Surgical, Inc.
Matched: Brand · Product details — Changes were made to the Stapler EndoWrist Stapler 45 System Instruments and Accessories User Manual Addendum (550986-03) and the EndoWrist Stapler…
FDA (openFDA device enforcement)
Reported Jul 16, 2014
Patient Side Cart Battery Box used in conjunction with the da Vinci A surgical system. Intuitive Surgical Inc.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intuitive Surgical, Inc.
Matched: Brand · Product · Product details — Patient Side Cart battery boxes may overheat in rare charging conditions, causing battery bulging.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 9, 2014
System Manual for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intuitive Surgical, Inc.
Matched: Brand · Product · Product details · Reason for recall — Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da…
11 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 2, 2014
IS4000 da Vinci Xi - Endoscope accessory; 30 Degree, 8mm Endoscope. Intuitive Surgical Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intuitive Surgical, Inc.
Matched: Brand · Product · Product details · Reason for recall — In some procedures when using the endoscope in conjunction with the IS4000 (da Vinci Xi) System, the surgical view has an orange-yellow tint which…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 11, 2014
Patient Side Cart assembly, 4-arm, for use with Intuitive Surgical, Inc. da Vinci Surgical System IS 4000. The…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intuitive Surgical, Inc.
Matched: Brand · Product · Product details — Torque wrenches used to tighten certain PSC bolts were out of calibration. This could lead to over- or under-tightening of bolts that may result in…
FDA (openFDA device enforcement)
Reported Apr 16, 2014
5X300 MM Curved Cannula, Arm 1 for use with daVinci SI Surgical System, model number IS3000. Intuitive Surgical 1266…
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 Surgical has become aware of the potential for certain lots of the Single-Site 5mm Curved Cannulae to become damaged during use. The second…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 25, 2013
Mega Needle Driver, 8MM assembly of the da Vinci S IS1200 and da Vinci Si, IS2000. Manufactured by Intuitive Surgical,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intuitive Surgical, Inc.
Matched: Brand · Product · Product details — Firm has become aware of the potential for detachment of the jaw insert for Large Needle Drivers and Mega Needle Drivers.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 11, 2013
Assembly, Patient Side Manipulator on da Vinci Surgical Systems: da Vinci S Surgical System; da Vinci SI Surgical…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intuitive Surgical, Inc.
Matched: Brand · Product · Product details — Reports of friction within certain instrument arms can interrupt smooth instrument motion. This can be felt by the surgeon as resistance in the…
FDA (openFDA device enforcement)
Reported Nov 13, 2013
Patient Cart used in conjunction with the da Vinci S surgical and SI System. Intuitive Surgical 1266 Kifer Road…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intuitive Surgical, Inc.
Matched: Brand · Product · Product details — Increased number of complaints regarding fluid entering the patient card base of the da Vinci S and SI systems.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 6, 2013
da Vinci Si Surgical System IS3000 with the da Vinci Surgeon Console which contains a high Resolution Stereoscopic…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intuitive Surgical, Inc.
Matched: Brand · Product · Product details — Improper restraints during transportation of the da Vinci system could cause the HRSV Monitor to become loose from its mount.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 17, 2013
da Vinci Si Surgeon Side Cart, model number SS3000; Manufactured by Intuitive Surgical, Sunnyvale, CA 94086. Intuitive…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intuitive Surgical, Inc.
Matched: Brand · Product · Product details · Reason for recall — Factory testing on da Vinci Si Surgical Systems may not be in compliance with UL Standards as one of the testing devices was found to be working…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 12, 2013
8 mm Monopolar Curved Scissors (a.k.a. Hot Shears) Manufactured and Distributed by: Intuitive Surgical Sunny vale, CA…
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 Surgical has identified a potential for some units of the Monopolar curved Scissors version 09 and 10 instruments to develop very small…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 5, 2013
User Manual addendum, TORS for da Vinci Surgical System IS 1200, IS 2000 and IS 3000. Product Usage: The user manual…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intuitive Surgical, Inc.
Matched: Brand · Product · Product details — Change to User Manual to remove one indication for use and amend warnings to emphasize restrictions for use.
8 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 24, 2013
IS2000 USER MANUAL for Intuitive Surgical da Vinci S Surgical System, Model IS2000. Arm drapes protect equipment from…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intuitive Surgical, Inc.
Matched: Brand · Product · Product details — Revised instructions for users of the da Vinci S, Si and Si-e systems with additional information regarding sterile adapter engagement and instrument…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 19, 2012
Tip Cover for 8mm Monopolar Curved Scissors (Hot Shears)Accessory, Disposable, 8mm MCS, Box of 10. The intended use of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intuitive Surgical, Inc.
Matched: Brand · Product details — There is potential for the sterility of the product to be compromised.
FDA (openFDA device enforcement)
Reported Aug 8, 2012
INSTRUMENT ARM DRAPE IS2000, 20 PACK: Product Usage: The intended use of the Instrument arm drape is to protect…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intuitive Surgical, Inc.
Matched: Brand · Product details — Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have difficulty engaging an instrument.
5 more products in this recall
FDA (openFDA device enforcement)
RecallNow is not a government agency. Every notice above is published by the FDA, USDA FSIS, or CPSC and links back to its source. Back to the look-up