PlainRecalls

Intuitive Surgical, Inc.

169 recalls on record · Latest: Feb 18, 2026

Intuitive Surgical, Inc. Recall Insight

Intuitive Surgical, Inc. appears on 169 federal recall records indexed by PlainRecalls, out of 83,949 total recalls tracked across the FDA, CPSC, NHTSA, and USDA FSIS. That represents approximately 0.201% of the federal archive — a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Feb 18, 2026, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 50 entries, severity tagging shows 0 critical, 50 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 50 of 50 entries — unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (50). The date window on this page runs from May 13, 2020 to Feb 18, 2026.

Manufacturer-level browsing is useful when monitoring a single firm for patterns — whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current — deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement — always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Moderate Feb 18, 2026

da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Number: 380730-45

FDA Devices Moderate Jan 21, 2026

da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 (2.7-4cm,SP1098, Box) & 430075 (2.7-7cm,SP1098,Box)

FDA Devices Moderate Dec 31, 2025

da Vinci 5, Surgeon Console Column Motor Connector; ASSY,DV5 CONSOLE,SSC,IS5000; Part Number: 380730-40

FDA Devices Moderate Mar 19, 2025

Brand Name: Da Vinci 5 Product Name: ASSY,DV5 CONSOLE,IS5000 Foot Tray Pedals Model/Catalog Number: 380730 Software Version: N/A . Refer to H…

FDA Devices Moderate Jan 22, 2025

8MM,HORIZON SMALL CLIP APPLIER,IS4000¿ REF 470401

FDA Devices Moderate Jan 22, 2025

8MM,MEGA SUTURECUT ND,IS4000 REF 471309

FDA Devices Moderate Jan 22, 2025

8MM, LARGE NEEDLE DRIVER, IS4000 REF 470006

FDA Devices Moderate Jan 22, 2025

8MM,PROGRASP FORCEPS,IS4000 REF 471093

FDA Devices Moderate Jan 22, 2025

8MM, MONOPOLAR CURVED SCISSORS, IS4000 REF 470179

FDA Devices Moderate Jan 22, 2025

8MM,ATRIAL RETRACTOR SHORT RIGHT,IS4000¿ REF 470246

FDA Devices Moderate Jan 22, 2025

8MM,FENESTRATED BIPOLAR FORCEPS,IS4000¿ REF 470205

FDA Devices Moderate Jan 22, 2025

8MM,LONG TIP FORCEPS,IS4000 REF 471048

FDA Devices Moderate Jan 22, 2025

8MM,BLACK DIAMOND MICRO FORCEPS,IS4000 ¿ REF 470033

FDA Devices Moderate Jan 22, 2025

8MM,RESANO FORCEPS,IS4000 ¿ REF 470181

FDA Devices Moderate Jan 22, 2025

8MM,MEGA NEEDLE DRIVER,IS4000¿ REF 470194

FDA Devices Moderate Jan 22, 2025

8MM,CADIERE FORCEPS,IS4000 REF 471049

FDA Devices Moderate Jan 22, 2025

8MM,PROGRASP FORCEPS,IS4000 ¿ REF 470093

FDA Devices Moderate Jan 22, 2025

8MM,MARYLAND BIPOLAR FORCEPS,IS4000 ¿ REF 470172

FDA Devices Moderate Jan 22, 2025

8MM,DEBAKEY FORCEPS,IS4000 ¿ REF 470036

FDA Devices Moderate Jan 22, 2025

8MM,MARYLAND BIPOLAR FORCEPS,IS4000 REF 471172

FDA Devices Moderate Jan 22, 2025

8MM, Small Graptor REF 470318 Is a grasping retractor Instrument used with the da Vinci X/Xi Surgical Systems in a wide variety of procedures to p…

FDA Devices Moderate Jan 22, 2025

8MM,FORCE BIPOLAR,IS4000 REF 471405

FDA Devices Moderate Jan 22, 2025

8MM, Tenaculum Forceps REF 470207 Instrument used with the da Vinci X/Xi Surgical Systems in a wide variety of procedures to perform a variety of …

FDA Devices Moderate Jan 22, 2025

8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000 REF 471296

FDA Devices Moderate Jan 22, 2025

8MM,CURVED BIPOLAR DISSECTOR,IS4000 REF 471344

FDA Devices Moderate Jan 22, 2025

8MM,MICRO BIPOLAR FORCEPS,IS4000 REF 471171

FDA Devices Moderate Sep 4, 2024

Ion Endoluminal System, REF: 380748-65

FDA Devices Moderate Dec 6, 2023

Da Vinci Single-Site Wristed Needle Driver, REF: 478115, 5 mm

FDA Devices Moderate Jul 12, 2023

da Vinci Xi/X Tip-Up Fenestrated Grasper, REF: 470347, VER: 12

FDA Devices Moderate Apr 5, 2023

da Vinci Xi Surgical System Model IS4000 da Vinci X Surgical System Model IS4200

FDA Devices Moderate Mar 22, 2023

Patient Side Cart, REF: 380620, with instrument arms, used as part of the da Vinci X Surgical System, REF: IS4200; Patient Side Cart, REF: 380652,…

FDA Devices Moderate Dec 7, 2022

INTUITIVE Da Vinci Xi 8mm SureForm 30 Curved-Tip Stapler Da Vinci Xi|X REF 488530 INTUITIVE Da Vinci 8mm SureForm 30 Reload 30 mm Gray 4-Row 2.0 m…

FDA Devices Moderate Nov 2, 2022

da Vinci X (IS4200) and Xi (IS4000) systems, which consists of finished devices Surgeon Console (SSC), Patient Cart (PSCART), Vision System (VSS)

FDA Devices Moderate Aug 10, 2022

The E-100 Generator (PN 374848-09) is a bipolar electrosurgical unit (ESU) designed to be used with the da Vinci Xi and X systems. The E-100 is insta…

FDA Devices Moderate Aug 3, 2022

Da Vinci S/Si Large Clip Applier, Model 420230 Da Vinci S/Si Medium-Large Clip Applier, Model 420327 Da Vinci S/Si Small Clip Applier, Model 420003

FDA Devices Moderate Jun 8, 2022

VESSEL SEALER EXTEND, Single-Use Instrument EndoWrist Instruments 8mm, da Vinci X' da Vinci Xi', REF 480422

FDA Devices Moderate Jun 8, 2022

DAVINCI | Energy SynchroSeal da Vinci X' da Vinci Xi', Single Use Instrument 8mm, REF 480440

FDA Devices Moderate May 4, 2022

da Vinici X da Vinci Xi Sureform 45 REF 480445 da Vinci X da Vinci Xi Sureform 45 Curved-Tip REF 480545 da Vinici X da Vinci Xi Sureform 60 …

FDA Devices Moderate Mar 9, 2022

da Vinci Xi and X 12-8 mm Conductive Cannula Reducer, REF: 470381-11

FDA Devices Moderate Dec 1, 2021

The da Vinci Xi and X surgical systems (IS4000 and IS4200) each consist of three main components: the Surgeon Console (SC), the Vision Cart (VC), and…

FDA Devices Moderate Oct 20, 2021

Ion Flexison Biopsy Needle, 19G, Extension Range : 0-3 cm, Ref: 490104-09 and 49004-10, 5-pack, Sterile EO, Rx only, UDI:00886874115978

FDA Devices Moderate Dec 2, 2020

Box Label: ION Fully Articulating Catheter, REF 490105, VER 08 - Product Usage: used to navigate the Ion Fully Articulating Catheter within the lung …

FDA Devices Moderate Nov 4, 2020

da Vinci Surgical System, IS 4000; Endoscope Controller, Model Number: 372601-16 (UDI: 00886874114193) is included in the IS 4000 Vision Cart, Model …

FDA Devices Moderate Sep 16, 2020

Ion Catheter Reprocessing Cover, IF1000 (Part Number:490114-02) UDI:00886874116845.

FDA Devices Moderate Jun 17, 2020

STAINLESS STEEL REPROCESSING TRAY, 8MM ENDOSCOPE, IS4000, Model No. 400498-02 - Product Usage: is designed to enable complex surgery using a minimall…

FDA Devices Moderate Jun 10, 2020

da Vinci SP surgical system

FDA Devices Moderate Jun 3, 2020

da Vinci SP Camera; PN 430060-33; Model Number: 430060-33. For endoscopic surgery.

FDA Devices Moderate May 20, 2020

da Vinci Xi Surgical System

FDA Devices Moderate May 20, 2020

da Vinci X Surgical System

FDA Devices Moderate May 13, 2020

daVinci XI Sureform 60 Reload, 60 mm black 6-Row 4.6 mm, Ref: 48360T-08 , UDI: 00886874113851, Rx only, SterileEO - Product Usage: are intended to b…

Nearby Manufacturers

Other firms with recall activity tracked in the PlainRecalls index.

Compare Intuitive Surgical, Inc. with FORD →

Data Sources

  • Source: FDA + CPSC + NHTSA + USDA FSIS — federal recall filings naming this firm. Verify with FDA, CPSC, NHTSA, or USDA FSIS directly.
  • Source: PlainRecalls Manufacturer Index — firm-level aggregation across all four federal recall feeds