Intuitive Surgical, Inc.

Complete recall history across all FDA and CPSC categories, 244 total recalls

Intuitive Surgical, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (244)

FDA medical device enforcement actions by Intuitive Surgical, Inc.. Showing most recent 50.

Date Product Reason Class
Apr 24, 2026 Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Nu... Due to unintentionally activated near infrared handheld camera when attemptin... Class II
Apr 22, 2026 Da Vinci ASSY, PSS, SP1098, Part Number: 380601 Operative components of surgical systems potentially distributed with E-brake... Class II
Apr 2, 2026 Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X, Xi Surgica... Due to manipulator containing screws with in the arm sub-assembly that my be ... Class II
Mar 11, 2026 Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48... Reloads for curved-tipped stapler may potentially produce an incomplete stapl... Class I
Dec 30, 2025 da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Nu... Robotic-assisted surgical system has Viewer Display manufactured with outdate... Class II
Dec 15, 2025 da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 ... Access Port System tray may develop cracks potentially resulting in a steril... Class II
Dec 9, 2025 Brand Name: da Vinci S, Si Tenaculum Forceps Instrument Product Name: da Vin... Due to increased in complaints regarding frayed or broken pitch cables on reu... Class II
Dec 9, 2025 Brand Name: da Vinci S, Si Double Fenestrated Grasper Instrument Product Nam... Due to increased complaints for broken/frayed grip cables for reusable instru... Class II
Dec 9, 2025 Brand Name: da Vinci S, Si Monopolar Curved Scissors Instrument Product Name... Due to increased complaints for broken/frayed grip cables for reusable instru... Class II
Dec 9, 2025 Brand Name: da Vinci S, Si Grasping Retractor Instrument Product Name: da Vi... Due to increased complaints for broken/frayed grip cables for reusable instru... Class II
Dec 9, 2025 Brand Name: da Vinci S, Si Mega Needle Driver Instrument Product Name: da Vi... Due to increased complaints for broken/frayed grip cables for reusable instru... Class II
Dec 9, 2025 Brand Name: da Vinci S, Si Permanent Cautery Hook Instrument Product Name: d... Due to increased in complaints regarding frayed or broken pitch cables on reu... Class II
Dec 4, 2025 Brand Name: Ion Endoluminal System Product Name: Ion Vision Probe Bag Model... Due to probe bags that may have a compromised or incomplete sterile pouch seal. Class II
Nov 17, 2025 Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used... An error event following the release of a software version for the surgical s... Class II
Nov 7, 2025 Brand Name: Da Vinci Product Name: da Vinci X, Xi Surgical System, & da Vin... Due to a software implementation error that allowed instruments arms failing ... Class II
May 12, 2025 da Vinci SP Instrument Arm Drape, SP, 1-PACK, Part Number: 430013-13, 430013-15 Robotic-assisted surgical system arm drapes may detach from the instrument ar... Class II
Feb 26, 2025 Brand Name: Da Vinci 5 Product Name: ASSY,DV5 CONSOLE,IS5000 Foot Tray Pedal... Due to an increase in complaints concerning foot tray pedal spring failing r... Class II
Dec 19, 2024 8MM,FENESTRATED BIPOLAR FORCEPS,IS4000 REF 471205 Due to increased complaints regarding frayed or broken grip cables on reusabl... Class II
Dec 19, 2024 8MM,LONG BIPOLAR GRASPER,IS4000 REF 471400 Due to increased complaints regarding frayed or broken grip cables on reusabl... Class II
Dec 19, 2024 8MM,MEGA SUTURECUT ND,IS4000¿ REF 470309 Due to increased complaints regarding frayed or broken grip cables on reusabl... Class II
Dec 19, 2024 8MM,TENACULUM FORCEPS,IS4000¿ REF 470207 Due to increased complaints regarding frayed or broken grip cables on reusabl... Class II
Dec 19, 2024 8MM,CADIERE FORCEPS,IS4000 ¿ REF 470049 Due to increased complaints regarding frayed or broken grip cables on reusabl... Class II
Dec 19, 2024 8MM,DUAL BLADE RETRACTOR,IS4000¿ REF 470249 Due to increased complaints regarding frayed or broken grip cables on reusabl... Class II
Dec 19, 2024 8MM,TIP-UP FENESTRATED GRASPER,IS4000¿ REF 470347 Due to increased complaints regarding frayed or broken grip cables on reusabl... Class II
Dec 19, 2024 8MM,SMALL GRASPING RETRACTOR,IS4000¿ REF 470318 Due to increased complaints regarding frayed or broken grip cables on reusabl... Class II
Dec 19, 2024 8MM,COBRA GRASPER,IS4000 REF 471190 Due to increased complaints regarding frayed or broken grip cables on reusabl... Class II
Dec 19, 2024 8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000¿ REF 470296 Due to increased complaints regarding frayed or broken grip cables on reusabl... Class II
Dec 19, 2024 8MM,MICRO BIPOLAR FORCEPS,IS4000 ¿ REF 470171 Due to increased complaints regarding frayed or broken grip cables on reusabl... Class II
Dec 19, 2024 8MM,MEDIUM-LARGE CLIP APPLIER,IS4000¿ REF 470327 Due to increased complaints regarding frayed or broken grip cables on reusabl... Class II
Dec 19, 2024 8MM, POTTS SCISSORS, IS4000 REF 470001 Due to increased complaints regarding frayed or broken grip cables on reusabl... Class II
Dec 19, 2024 8MM,LARGE HEM-O-LOK CLIP APPLIER,IS4000¿ REF 470230 Due to increased complaints regarding frayed or broken grip cables on reusabl... Class II
Dec 19, 2024 8MM,CURVED BIPOLAR DISSECTOR,IS4000¿ REF 470344 Due to increased complaints regarding frayed or broken grip cables on reusabl... Class II
Dec 19, 2024 8MM,FORCE BIPOLAR,IS4000 REF 470405 Due to increased complaints regarding frayed or broken grip cables on reusabl... Class II
Dec 19, 2024 8MM, ROUND TIP SCISSORS, IS4000 ¿ REF 470007 Due to increased complaints regarding frayed or broken grip cables on reusabl... Class II
Dec 19, 2024 8MM,MICRO BIPOLAR FORCEPS,IS4000 REF 471171 Due to increased complaints regarding frayed or broken grip cables on reusabl... Class II
Dec 19, 2024 8MM,CURVED BIPOLAR DISSECTOR,IS4000 REF 471344 Due to increased complaints regarding frayed or broken grip cables on reusabl... Class II
Dec 19, 2024 8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000 REF 471296 Due to increased complaints regarding frayed or broken grip cables on reusabl... Class II
Dec 19, 2024 8MM, Tenaculum Forceps REF 470207 Instrument used with the da Vinci X/Xi S... Due to an increase in complaints for pitch cable failures related to forceps ... Class II
Dec 19, 2024 8MM,FORCE BIPOLAR,IS4000 REF 471405 Due to increased complaints regarding frayed or broken grip cables on reusabl... Class II
Dec 19, 2024 8MM, Small Graptor REF 470318 Is a grasping retractor Instrument used with... Due to an increase in complaints for pitch cable failures related to forceps ... Class II
Dec 19, 2024 8MM,MARYLAND BIPOLAR FORCEPS,IS4000 REF 471172 Due to increased complaints regarding frayed or broken grip cables on reusabl... Class II
Dec 19, 2024 8MM,DEBAKEY FORCEPS,IS4000 ¿ REF 470036 Due to increased complaints regarding frayed or broken grip cables on reusabl... Class II
Dec 19, 2024 8MM,MARYLAND BIPOLAR FORCEPS,IS4000 ¿ REF 470172 Due to increased complaints regarding frayed or broken grip cables on reusabl... Class II
Dec 19, 2024 8MM,PROGRASP FORCEPS,IS4000 ¿ REF 470093 Due to increased complaints regarding frayed or broken grip cables on reusabl... Class II
Dec 19, 2024 8MM,CADIERE FORCEPS,IS4000 REF 471049 Due to increased complaints regarding frayed or broken grip cables on reusabl... Class II
Dec 19, 2024 8MM,MEGA NEEDLE DRIVER,IS4000¿ REF 470194 Due to increased complaints regarding frayed or broken grip cables on reusabl... Class II
Dec 19, 2024 8MM,RESANO FORCEPS,IS4000 ¿ REF 470181 Due to increased complaints regarding frayed or broken grip cables on reusabl... Class II
Dec 19, 2024 8MM,BLACK DIAMOND MICRO FORCEPS,IS4000 ¿ REF 470033 Due to increased complaints regarding frayed or broken grip cables on reusabl... Class II
Dec 19, 2024 8MM,LONG TIP FORCEPS,IS4000 REF 471048 Due to increased complaints regarding frayed or broken grip cables on reusabl... Class II
Dec 19, 2024 8MM,FENESTRATED BIPOLAR FORCEPS,IS4000¿ REF 470205 Due to increased complaints regarding frayed or broken grip cables on reusabl... Class II

View all 244 device recalls →

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious, there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious, the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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