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 19 entries, severity tagging shows 0 critical, 19 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 19 of 19 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 (19). The date window on this page runs from Aug 8, 2012 to Nov 6, 2013.

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 Nov 6, 2013

da Vinci Si Surgical System IS3000 with the da Vinci Surgeon Console which contains a high Resolution Stereoscopic Viewer. Intended to assist in t…

FDA Devices Moderate Nov 6, 2013

Single Site Curved Needed Driver Intuitive Surgical, Sunnyvale, CA. 94086 The Intuitive Surgical da Vinci Single-Site Instruments and Accessori…

FDA Devices Moderate Jul 17, 2013

da Vinci Si Vision System Cart, model number VS3000; Manufactured by Intuitive Surgical, Sunnyvale, CA 94086. Intuitive Surgical endoscopic Ins…

FDA Devices Moderate Jul 17, 2013

da Vinci Dual Camera Controller, model number DC3000; Manufactured by Intuitive Surgical, Sunnyvale, CA 94086. Intuitive Surgical endoscopic In…

FDA Devices Moderate Jun 12, 2013

da Vinci 5 mm Instrument Cannulae for use with the da Vinci S and Si Surgical Systems. Used to establish a port of entry for Intuitive Surgical En…

FDA Devices Moderate Jun 12, 2013

da Vinci 5 mm Flared Instrument Cannulae for use with the da Vinci S and Si Surgical Systems. Used to establish a port of entry for Intuitive Surg…

FDA Devices Moderate Jun 5, 2013

8mm Maryland Bipolar Forceps used in conjunction with the da Vinci Surgical System, Model IS1200. Multiple use electrosurgical endoscopic instrume…

FDA Devices Moderate Jun 5, 2013

da Vinci Si Surgeon Console. Intended to assist in the accurate Control of Intuitive Surgical Endoscopic Instruments.

FDA Devices Moderate Jun 5, 2013

8mm Precise Bipolar Forceps used in conjunction with the da Vinci Surgical System, Model IS1200. Multiple use electrosurgical endoscopic instrume…

FDA Devices Moderate Jun 5, 2013

Flush Port (used in almost all da Vinci instruments) Assists in cleaning the instrument.

FDA Devices Moderate Jun 5, 2013

User Manual addendum, TORS for da Vinci Surgical System IS 1200, IS 2000 and IS 3000. Product Usage: The user manual for Transoral Surgery (TORS…

FDA Devices Moderate Jun 5, 2013

Thyroidectomy Indication for the da Vinci Surgical Systems; Product Usage: da Vinci Thyroidectomy offers a minimally invasive surgery for both pa…

FDA Devices Moderate Jun 5, 2013

8mm Fenestrated Bipolar Forceps used in conjunction with the da Vinci Surgical System, Model IS1200. Multiple use electrosurgical endoscopic inst…

FDA Devices Moderate Apr 24, 2013

IS3000 USER MANUAL for Intuitive Surgical da Vinci Si Surgical System and da Vinci Si-e Surgical System, Model SI3000. Arm drapes protect equipmen…

FDA Devices Moderate Apr 24, 2013

IS2000 USER MANUAL for Intuitive Surgical da Vinci S Surgical System, Model IS2000. Arm drapes protect equipment from contamination.

FDA Devices Moderate Aug 8, 2012

KIT,DISPOSABLE ACCESSORY,3ARM,IS3000,5 PACK; Product Usage: The intended use of the Instrument arm drape is to protect equipment from contamin…

FDA Devices Moderate Aug 8, 2012

KIT,DISPOSABLE ACCESSORY,4ARM,IS2000,5 PACK; Product Usage: The intended use of the Instrument arm drape is to protect equipment from contamin…

FDA Devices Moderate Aug 8, 2012

ACCESSORY BASE STARTER KIT,IS3000; Product Usage: The intended use of the Instrument arm drape is to protect equipment from contamination and…

FDA Devices Moderate Aug 8, 2012

KIT,DISPOSABLE ACCESSORY,4ARM,IS3000,5 PACK; Product Usage: The intended use of the Instrument arm drape is to protect equipment from contami…

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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