Manufacturer

Intuitive Surgical, Inc.

257 recalls in our database name Intuitive Surgical, Inc. as the manufacturing or recalling firm.

What the numbers show

Total: 257
Critical: 0
Severe: 15
Most recent: 2026-07-22

Of the 257 recalls from Intuitive Surgical, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 15 (6%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

126–150 of 257

SevereFDA (Devices)·Z-2677-2016·2016-09-07
Intuitive Surgical Recalls da Vinci EndoWrist Stapler 30 Instruments
Intuitive Surgical is recalling 875 da Vinci EndoWrist Stapler 30 instruments due to reported shaft rotation interruptions and jaw opening failures.
Product
CURVED-TIP STAPLER 30,IS4000; Model number 470530; General and Plastic Surgery: The Intuitive Surgical da Vinci EndoWrist Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and/or
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2675-2016·2016-09-07
Intuitive Surgical da Vinci EndoWrist Stapler 45 Recall for Field Failures
Intuitive Surgical is recalling da Vinci EndoWrist Stapler 45 instruments due to reported field failures involving shaft rotation interruptions and jaw opening issues.
Product
STAPLER,IS4000; Model number 470298; General and Plastic Surgery: The Intuitive Surgical da Vinci EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and/
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2348-2016·2016-08-17
Intuitive Surgical da Vinci EndoWrist Stapler 45 Recall for Firing Failures
Intuitive Surgical is recalling da Vinci EndoWrist Stapler 45 devices due to an increased trend of stapler firing failures.
Product
STAPLER 45, IS4000, model number 470298 Gastroenterology/Urology: The Intuitive Surgical da Vinci EndoWrist¿ Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2350-2016·2016-08-17
Intuitive Surgical Recalls da Vinci EndoWrist Stapler 30 Instruments
Intuitive Surgical is recalling da Vinci EndoWrist Stapler 30 instruments and reloads due to an increased trend of firing failures.
Product
CURVED-TIP STAPLER 30,IS4000, model number 470530; Gastroenterology/Urology: The Intuitive Surgical da Vinci EndoWrist Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and/or cr
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2349-2016·2016-08-17
Intuitive Surgical Recalls da Vinci EndoWrist Stapler 30 Instruments
Intuitive Surgical is recalling da Vinci EndoWrist Stapler 30 instruments and reloads due to an increased trend of 'Stapler Firing Failed' messages.
Product
STAPLER 30, IS4000, model number 470430; Gastroenterology/Urology: The Intuitive Surgical da Vinci EndoWrist Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and/or creation of
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1836-2016·2016-06-08
Intuitive Surgical Recalls da Vinci Xi Cannula Seals Due to Particulate Risk
Intuitive Surgical is recalling da Vinci Xi cannula seals because particulates may enter the cannula lumen during surgery, potentially affecting patients.
Product
SEAL,IS4000 PORTS,5MM-8MM,BOX of 10; Model numbers: 470361-03, 470361-04, 470361-05, 470361-06; Part number: 470361. The da Vinci Xi Surgical System cannula sterile single use disposable cap for each cannula . When attached to the cannula, the seal maintains insufflation when th
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1837-2016·2016-06-08
Intuitive Surgical Recalls da Vinci Xi Cannula Seals Due to Particulate Risk
Intuitive Surgical is recalling da Vinci Xi Surgical System cannula seals because particulates could enter the cannula lumen during surgery.
Product
SEAL,IS4000 PORTS,12MM&STAPLER,BOX of 10; Model numbers: 470380-04, 470380-05, 470380-06; Part number:470380. The da Vinci Xi Surgical System cannula seal is used with the cannula accessory and provides sterile disposable cap for each cannula. When attached to the cannula, the s
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1568-2016·2016-05-04
Intuitive Surgical Recalls da Vinci Xi Stapler Instruments Due to Motion Risk
Intuitive Surgical is recalling 43 EndoWrist Stapler instruments for the da Vinci Xi system due to a risk of unexpected jaw motion during use.
Product
EndoWrist Stapler 45 and Stapler 30 instruments used on the da Vinci Xi systems (IS4000) with p5 software. General Surgery: The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of In
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1376-2016·2016-04-20
Intuitive Surgical Recalls da Vinci S Surgical System User Manuals
Intuitive Surgical is recalling da Vinci S Surgical System user manuals because using certain instruments with ablation probes can increase microscopic metallic particulates.
Product
da Vinci S Surgical System (IS1200/IS2000/IS3000) user manual, instrument & accessory. Product Usage: The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endosco
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1377-2016·2016-04-20
Intuitive Surgical Recalls da Vinci S Surgical System User Manuals
Intuitive Surgical is recalling da Vinci S Surgical System user manuals because using non-approved instruments with ablation probes may increase microscopic metallic particulates.
Product
da Vinci S Surgical System (IS4000) user manual English and OUS. Product Usage: The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments inclu
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1191-2016·2016-03-30
Intuitive Surgical Recalls da Vinci Surgeon Side Console Touchpads
Intuitive Surgical is recalling 542 da Vinci Si and Xi Surgeon Side Console touchpads due to a Class II defect. The recall covers units distributed in the US and 33 other countries.
Product
da Vinci Si (IS3000) and da Vinci Xi (IS4000) Surgeon Side Console (SSC)Touchpad; Model number 187505-04; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. The system can also be employed with adjunctive mediastinotomy to perform coronary a
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0652-2016·2016-01-20
Intuitive Surgical Recalls da Vinci Xi 8mm Endoscopes for Safety Manual Correction
Intuitive Surgical is correcting the da Vinci Xi I&A User Manual to prevent unintended patient harm from capacitive coupling when using 8mm endoscopes with specific instruments.
Product
0 deg, 8mm Endoscope, IS4000: Model numbers: 470026-34, 470026-40, 470026-41. General and Plastic Surgery: The da Vinci Xi endoscope produces high definition (HD), visible light (VIS). The HD video is processed by the system electronics in the Vision Cart and displayed on th
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0653-2016·2016-01-20
Intuitive Surgical Recalls da Vinci Xi Endoscopes for Capacitive Coupling Risk
Intuitive Surgical is correcting the da Vinci Xi I&A User Manual to warn about unintended patient harm from capacitive coupling when using 8 mm endoscopes with specific instruments.
Product
30 deg, 8mm Endoscope, IS4000: Model numbers: 470027-34, 470027-40, 470027-41. General and Plastic Surgery: The da Vinci Xi endoscope produces high definition (HD), visible light (VIS). The HD video is processed by the system electronics in the Vision Cart and displayed on t
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2782-2015·2015-09-23
Intuitive Surgical Recalls Fluorescence Imaging Kits Due to Packaging Damage
Intuitive Surgical is recalling 1,200 Fluorescence Imaging Procedure Kits because shipping damage may have compromised the sterile packaging of the stopcocks.
Product
Fluorescence Imaging Procedure Kits used with the da Vinci Si and Xi Surgical Systems; Model numbers: 950156-01, 950156-02, 950156-03. Product Usage: General and plastic surgery: The da Vinci Firefly Imaging system is intended to provide real-time endoscopic visible and near
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2750-2015·2015-09-16
Intuitive Surgical Recalls da Vinci Si Single-Site Maryland Dissector Instruments
Intuitive Surgical is recalling 8,217 Maryland Dissector instruments used with the da Vinci Si Surgical System because the jaws may become fixed in a closed position.
Product
Maryland Dissector; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428050-12, 428050-13 and 428050-14; The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by train
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2754-2015·2015-09-16
Intuitive Surgical Recalls da Vinci Si Single-Site Fundus Graspers
Intuitive Surgical is recalling 6,309 Fundus Graspers used with the da Vinci Si Surgical System because the jaws may become fixed in a closed position.
Product
Fundus Grasper; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428058-12, 428058-13. The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2758-2015·2015-09-16
Intuitive Surgical Recalls Fenestrated Bipolar Forceps for da Vinci System
Intuitive Surgical is recalling 21,684 Fenestrated Bipolar Forceps used with the da Vinci Si Surgical System because the jaws may become fixed in a closed position.
Product
Fenestrated Bipolar Forceps; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428093-12, 428093-13. The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained p
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2753-2015·2015-09-16
Intuitive Surgical Recalls da Vinci Si Single-Site Needle Drivers
Intuitive Surgical is recalling 89 da Vinci Si Single-Site Needle Drivers because the jaws may become fixed in a closed position.
Product
Needle Driver; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428056-12, 428056-13. The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in a
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2755-2015·2015-09-16
Intuitive Surgical Recalls da Vinci Si Single-Site Crocodile Graspers
Intuitive Surgical is recalling 15,834 da Vinci Si Single-Site Crocodile Graspers because the instrument jaws may become fixed in a closed position.
Product
Crocodile Grasper; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428059-12, 428059-13. The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2751-2015·2015-09-16
Intuitive Surgical Recalls da Vinci Si Single-Site Clip Appliers
Intuitive Surgical is recalling 17,617 da Vinci Si Single-Site Clip Appliers because the jaws may become fixed in a closed position during use.
Product
Medium -Large Clip Applier; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428053-12, 428053-15. The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained ph
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2752-2015·2015-09-16
Intuitive Surgical Recalls Cadiere Forceps for da Vinci Si System
Intuitive Surgical is recalling Cadiere Forceps used with the da Vinci Si Surgical System because the instrument jaws may become fixed in a closed position.
Product
Cadiere Forceps; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428055-12, 428055-13. The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2757-2015·2015-09-16
Intuitive Surgical Recalls Curved Needle Drivers for da Vinci System
Intuitive Surgical is recalling 3,698 Curved Needle Drivers used with the da Vinci Si Surgical System because the jaws may become fixed in a closed position.
Product
Curved Needle Driver; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428088-12, 428088-13. The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicia
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2756-2015·2015-09-16
Intuitive Surgical Recalls da Vinci Si Maryland Bipolar Forceps
Intuitive Surgical is recalling 13,644 Maryland Bipolar Forceps used with the da Vinci Si Surgical System because the instrument jaws may become fixed in a closed position.
Product
Maryland Bipolar Forceps; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428080-04, 428080-05. The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained phys
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2734-2015·2015-09-09
Intuitive Surgical Recalls da Vinci Xi Systems Due to Exposed Knife Blade
Intuitive Surgical is recalling 198 da Vinci Xi Surgical Systems because the Xi Stapler may have an exposed knife blade when used with P4 software.
Product
da Vinci Xi Surgical System P4 software;with Xi Stapler; model number IS4000 : General and Plastic surgery: The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1949-2015·2015-07-08
Intuitive Surgical Recalls da Vinci Xi Instrument Arm Drapes
Intuitive Surgical is recalling da Vinci Xi Instrument Arm Drapes because a pinched drape may cause a 'Missing reload error' on the Vision Cart touchscreen.
Product
INSTRUMENT ARM DRAPE, IS4000, 20 PACK; used on the da Vinci Xi Surgical System. The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Category
Medical Device
Distribution
Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Intuitive Surgical

American corporation

Country: United States
Founded: 1995

Official website

Source: Wikidata (Q2743863), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.