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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

1

Class I (Serious)

0

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 61–80 of 105 recalls

Intuitive Surgical, Inc.: IS3000 Vision Side Cart (VSC) used in conjunction with th...

Intuitive Surgical is initiating a voluntary correction related to da Vinci Si System (IS3000) Vision Side Carts, with threaded-in caster wheels, which can result in the caster wheel bolts gradually unthreading and the wheels loosening.

Class IIModerate

FDADec 5, 2014Nationwide• Intuitive Surgical, Inc.

Intuitive Surgical, Inc.: Fluorescence Imaging Procedure Kit, designed for use wit...

The storage conditions for indocyanine green (ICG) are not on the individual Fluorescence Imaging Procedure Kit box, the six-kit box, and the shipping box. If heat were to damage the material, the result would be a loss of fluorescence.

Class IIModerate

FDANov 21, 2014Nationwide• Intuitive Surgical, Inc.

Intuitive Surgical, Inc.: Fluorescence Imaging Procedure Kit, designed for use wit...

Page 4 of 6Next

The storage conditions for indocyanine green (ICG) are not on the individual Fluorescence Imaging Procedure Kit box, the six-kit box, and the shipping box. If heat were to damage the material, the result would be a loss of fluorescence.

Class IIModerate

FDANov 21, 2014Nationwide• Intuitive Surgical, Inc.

Intuitive Surgical, Inc.: 8MM, DUAL BLADE RETRACTOR; Intended to assist in the a...

Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.

Class IIModerate

FDANov 3, 2014FL, IN, MA +5 more• Intuitive Surgical, Inc.

Intuitive Surgical, Inc.: 8MM,MICRO BIPOLAR FORCEPS; Intended to assist in the a...

Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.

Class IIModerate

FDANov 3, 2014FL, IN, MA +5 more• Intuitive Surgical, Inc.

Intuitive Surgical, Inc.: 8MM PERMANENT CAUTERY HOOK,; Intended to assist in the...

Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.

Class IIModerate

FDANov 3, 2014FL, IN, MA +5 more• Intuitive Surgical, Inc.

Intuitive Surgical, Inc.: 8MM, CARDIAC PROBE GRASPER; Intended to assist in the ...

Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.

Class IIModerate

FDANov 3, 2014FL, IN, MA +5 more• Intuitive Surgical, Inc.

Intuitive Surgical, Inc.: 8MM,POTTS SCISSORS; Intended to assist in the accurate...

Deviations in reprocessing steps from those stated in the reprocessing instructions, can cause surface degradation of the housing; and/or, accelerate mechanical wear of the instrument.

Class IIModerate

FDANov 3, 2014FL, IN, MA +5 more• Intuitive Surgical, Inc.

Intuitive Surgical, Inc.: 8MM,LONG TIP FORCEPS; Intended to assist in the accura...

Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.

Class IIModerate

FDANov 3, 2014FL, IN, MA +5 more• Intuitive Surgical, Inc.

Intuitive Surgical, Inc.: 8MM, TIP-UP FENESTRATED GRASPER; Intended to assist in...

Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.

Class IIModerate

FDANov 3, 2014FL, IN, MA +5 more• Intuitive Surgical, Inc.

Intuitive Surgical, Inc.: 8MM, TENACULUM FORCEPS; Intended to assist in the accu...

Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.

Class IIModerate

FDANov 3, 2014FL, IN, MA +5 more• Intuitive Surgical, Inc.

Intuitive Surgical, Inc.: 8MM MONOPOLAR CURVED SCISSORS; Intended to assist in ...

Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.

Class IIModerate

FDANov 3, 2014FL, IN, MA +5 more• Intuitive Surgical, Inc.

Intuitive Surgical, Inc.: 8MM, MEGA SUTURECUT ND; Intended to assist in the accu...

Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.

Class IIModerate

FDANov 3, 2014FL, IN, MA +5 more• Intuitive Surgical, Inc.

Intuitive Surgical, Inc.: 8MM RESANO FORCEPS,; Intended to assist in the accurat...

Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.

Class IIModerate

FDANov 3, 2014FL, IN, MA +5 more• Intuitive Surgical, Inc.

Intuitive Surgical, Inc.: 8MM,MEDIUM-LARGE CLIP APPLIER ; Intended to assist in ...

Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.

Class IIModerate

FDANov 3, 2014FL, IN, MA +5 more• Intuitive Surgical, Inc.

Intuitive Surgical, Inc.: 8MM, SMALL GRASPING RETRACTOR ; Intended to assist in ...

Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.

Class IIModerate

FDANov 3, 2014FL, IN, MA +5 more• Intuitive Surgical, Inc.

Intuitive Surgical, Inc.: 8MM,LARGE NEEDLE DRIVER; Intended to assist in the acc...

Deviations in reprocessing steps from those stated in the reprocessing instructions, can cause surface degradation of the housing; and/or, accelerate mechanical wear of the instrument.

Class IIModerate

FDANov 3, 2014FL, IN, MA +5 more• Intuitive Surgical, Inc.

Intuitive Surgical, Inc.: 8MM FENESTRATED BIPOLAR FORCEPS,; Intended to assist i...

Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.

Class IIModerate

FDANov 3, 2014FL, IN, MA +5 more• Intuitive Surgical, Inc.

Intuitive Surgical, Inc.: 8MM, ATRIAL RETRACTOR SHORT RIGHT ; Intended to assist...

Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.

Class IIModerate

FDANov 3, 2014FL, IN, MA +5 more• Intuitive Surgical, Inc.

Intuitive Surgical, Inc.: 8MM, LARGE HEM-O-LOK CLIP APPLIER; Intended to assist ...

Class IIModerate

FDANov 3, 2014FL, IN, MA +5 more• Intuitive Surgical, Inc.