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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

1000

Past Year

1000

Class I (Serious)

143

Most Recent

Jan 2026

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 2981–3000 of 37665 recalls

da Vinci 5 Console (Intuitive) – Connector Error (2024)

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

Low

FDAAug 21, 2024Nationwide• Intuitive Surgical, Inc.

Gastrointestinal Videoscope (Olympus) – Color Correction Problem (2024)

It was discovered during device performance testing that the CCD imaging sensors were programmed with the incorrect color correction data and therefore, specifications are not met.

Low

FDAAug 21, 2024Nationwide• Olympus Corporation of the Americas

Change Healthcare Cardiology Hemo (CHANGE HEALTHCARE) – Calculation Error (2024)

A potential issue has been identified in Change Healthcare Cardiology Hemo where incorrect data entry can lead to inaccurate hemodynamic calculations, potentially resulting in misdiagnosis and inappropriate treatment. This issue occurs when the unit of measurement (UOM) for hemoglobin is configured in a way that differs from the users understanding.

1...148 149150151 152...1884

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High

FDAAug 21, 2024Nationwide• CHANGE HEALTHCARE CANADA COMPANY

Positive bias in patient results at and below the cut-off of 60 U/mL with the lots listed in the table below when compared to alternate lots on the Atellica IM analyzer.

Moderate

FDAAug 21, 2024Nationwide• Siemens Healthcare Diagnostics, Inc.

Jolly Rancher Popsicle (Unilever) – Undeclared Milk (2024)

Undeclared Milk

Undeclared milk

Class IHigh

FDAAug 21, 2024Nationwide• Unilever North America Supply Chain Company, LLC

Cortera Spinal Fixation Screw (XTANT) – Implant Marking Issue (2024)

Spinal fixation system implant screws marked "DNI" are not intended to be implanted and may not have been manufactured in accordance with released manufacturing specifications, and if implanted the screws may not have adequate strength or performance.

Moderate

FDAAug 21, 2024Nationwide• XTANT Medical Holdings, Inc

Vanta Neurostimulator (Medtronic) – Battery Life Concern (2024)

Model 977006 Vanta INS batterty life has depleted faster than HCPs or patients expected leading to outpatient reprogramming or earlier than anticipated surgical replacements.

Moderate

FDAAug 21, 2024Nationwide• Medtronic Neuromodulation

ADVIA Centaur aTPO Assay (Siemens) – Result Bias (2024)

Laceration Risk

Positive bias in patient results at and below the cut-off of 60 U/mL with the lots listed in the table below when compared to alternate lots on the Atellica IM analyzer.

Moderate

FDAAug 21, 2024Nationwide• Siemens Healthcare Diagnostics, Inc.

Continental HDL2 DL+ Tire (CONTINENTAL) – Rubber Compound Risk (2024)

Continental Tire the Americas, LLC (Continental) is recalling certain HDL2 DL+ tires, size 11R24.5. An incorrect rubber compound may cause the steel belt edge to separate from the shoulder.

High

NHTSAAug 20, 2024Nationwide• CONTINENTAL

EXACTAMIX Inlet (Baxter) – Particulate Matter Concern (2024)

Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets (disposable inlet), Product Codes H938173, H938174, H938175, H938176, used with the ExactaMix and ExactaMix Pro compounders. Particulate matter has been observed within the inlet primary packaging inlet components, including within the sterile fluid path tubing, before use.

High

FDAAug 20, 2024Nationwide• Baxter Healthcare Corporation

EXACTAMIX Vented Inlet (Baxter) – Particulate Matter Concern (2024)

High

FDAAug 20, 2024Nationwide• Baxter Healthcare Corporation

Continental ProContact GX AO Tire (CONTINENTAL) – Tread Design Issue (2024)

Continental Tire the Americas, LLC (Continental) is recalling certain ProContact GX AO tires, size 255/35R19. The design of the tire may cause excessive heat buildup, resulting in belt separation.

High

NHTSAAug 20, 2024Nationwide• CONTINENTAL

Just Right 5000 Fluoride (Elevate Oral Care) – Label Mix-up (2024)

LABELING: LABEL MIX-UP.

Class IIILow

FDAAug 20, 2024Nationwide• Elevate Oral Care

Miami J Select Collar (Ossur) – Adhesive Hook Issue (2024)

Pressure sensitive adhesive hooks attached to the sides of the anterior cervical orthosis collar panel can occasionally exhibit poor adhesion, which may lead to them gradually peeling off with repeated doffing, possibly leading to reduced immobilization of the cervical spine.

Moderate

FDAAug 20, 2024AL, AK, AZ +36 more• Ossur H F Grjothals 5 Reykjavik Iceland

Blue Diamond Inflation Device (Merit Medical) – Sterile Barrier Breach (2024)

Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.

High

FDAAug 19, 2024Nationwide• Merit Medical Systems, Inc.

MONARCH Inflation Device (Merit Medical) – Sterile Barrier Breach (2024)

Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.

High

FDAAug 19, 2024Nationwide• Merit Medical Systems, Inc.

BlueFIRE Inflation Device (Merit Medical) – Sterile Barrier Breach (2024)

Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.

High

FDAAug 19, 2024Nationwide• Merit Medical Systems, Inc.

IntelliSystem Inflation Device (Merit Medical) – Sterile Barrier Breach (2024)

Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.

High

FDAAug 19, 2024Nationwide• Merit Medical Systems, Inc.

Stay Informed

Intuitive Surgical, Inc. Recalls

Recall Summary

da Vinci 5 Console (Intuitive) – Connector Error (2024)

Gastrointestinal Videoscope (Olympus) – Color Correction Problem (2024)

Change Healthcare Cardiology Hemo (CHANGE HEALTHCARE) – Calculation Error (2024)

Horizon Cardiology Hemo (CHANGE HEALTHCARE) – Calculation Error (2024)

McKesson Cardiology Hemo (CHANGE HEALTHCARE) – Calculation Error (2024)

Atellica IM aTPO Assay (Siemens) – Result Bias (2024)

Jolly Rancher Popsicle (Unilever) – Undeclared Milk (2024)

Cortera Spinal Fixation Screw (XTANT) – Implant Marking Issue (2024)

Vanta Neurostimulator (Medtronic) – Battery Life Concern (2024)

ADVIA Centaur aTPO Assay (Siemens) – Result Bias (2024)

Continental HDL2 DL+ Tire (CONTINENTAL) – Rubber Compound Risk (2024)

EXACTAMIX Inlet (Baxter) – Particulate Matter Concern (2024)

EXACTAMIX Vented Inlet (Baxter) – Particulate Matter Concern (2024)

Continental ProContact GX AO Tire (CONTINENTAL) – Tread Design Issue (2024)

Just Right 5000 Fluoride (Elevate Oral Care) – Label Mix-up (2024)

Miami J Select Collar (Ossur) – Adhesive Hook Issue (2024)

Blue Diamond Inflation Device (Merit Medical) – Sterile Barrier Breach (2024)

MONARCH Inflation Device (Merit Medical) – Sterile Barrier Breach (2024)

BlueFIRE Inflation Device (Merit Medical) – Sterile Barrier Breach (2024)

IntelliSystem Inflation Device (Merit Medical) – Sterile Barrier Breach (2024)