Intuitive Surgical, Inc. Recalls

11 recalls on record in the United States

medical: 11
medical Class II
2026-04-08

Intuitive Surgical, Inc. recalls Brand Name: da Vinci S, Si Permanent Cautery Hook Instrument

Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments

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medical Class II
2026-04-08

Intuitive Surgical, Inc. recalls Brand Name: da Vinci S, Si Mega Needle Driver Instrument Pr

Due to increased complaints for broken/frayed grip cables for reusable instruments.

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medical Class II
2026-04-08

Intuitive Surgical, Inc. recalls Brand Name: da Vinci S, Si Grasping Retractor Instrument Pr

Due to increased complaints for broken/frayed grip cables for reusable instruments.

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medical Class II
2026-04-08

Intuitive Surgical, Inc. recalls Brand Name: da Vinci S, Si Monopolar Curved Scissors Instrum

Due to increased complaints for broken/frayed grip cables for reusable instruments.

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medical Class II
2026-04-08

Intuitive Surgical, Inc. recalls Brand Name: da Vinci S, Si Double Fenestrated Grasper Instru

Due to increased complaints for broken/frayed grip cables for reusable instruments.

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medical Class II
2026-04-08

Intuitive Surgical, Inc. recalls Brand Name: da Vinci S, Si Tenaculum Forceps Instrument Pro

Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments

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medical Class II
2026-05-13

Intuitive Surgical, Inc. recalls Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vin

Due to manipulator containing screws with in the arm sub-assembly that my be susceptible to breaking.

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medical Class I
2026-05-13

Intuitive Surgical, Inc. recalls Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers:

Reloads for curved-tipped stapler may potentially produce an incomplete staple line.

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medical Class II
2026-06-10

Intuitive Surgical, Inc. recalls Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000

Due to unintentionally activated near infrared handheld camera when attempting to turn off illumination during normal clinical workflow transitions, particularly when switching from the handheld camera to the robotic endoscope.

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medical Class II
2026-07-01

Intuitive Surgical, Inc. recalls Da Vinci ASSY, PSS, SP1098, Part Number: 380601

Operative components of surgical systems potentially distributed with E-brake retainer pin, so in event of a structural column failure, the E-brake pin would prevent E-brake engagement and may result in uncontrolled motion. In addition, if it moves/backs out it may cause restricted column range of motion and/or uncontrolled motion, which may cause patient tissue injury/crushing injury/bleeding.

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medical Class II
2026-07-22

Intuitive Surgical, Inc. recalls da Vinci SP Instrument Arm Drape, SP, 1-PACK, Part Number: 4

Robotic-assisted surgical system arm drapes may detach from the instrument arm due to an issue involving the drape rings located at the top of the product, which may expose a section of instrument arm, which may result in procedure delay or conversion to an alternate minimally invasive approach. Retrospectively reported recall.

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