The Recall Desk
HighFDA (Devices)·Z-1697-2026·Announced 2026-04-08

da Vinci double fenestrated grasper recalled over broken grip cables

Intuitive Surgical is recalling da Vinci S and Si Double Fenestrated Grasper Instruments following increased complaints of broken or frayed grip cables in reusable instruments.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: broken or frayed drive cables in a robotic surgical instrument are a hazard during a procedure, and no injuries are stated.

Plain-English summary

Intuitive Surgical, Inc. is recalling the da Vinci S, Si Double Fenestrated Grasper Instrument, model 420189. The EndoWrist reusable instruments are intended for endoscopic manipulation of tissue, including grasping, cutting, dissection, ligation, electrocautery and suturing. About 2,370 units were distributed across 20 US states and more than twenty other countries. The FDA has classified this recall as Class II.

The recall follows increased complaints for broken or frayed grip cables in reusable instruments.

Affected product is listed by material number and system number in the FDA enforcement record.

Facilities can identify affected instruments by the model number above, and may contact Intuitive Surgical, Inc. for further information.

The recalled product

Product
Brand Name: da Vinci S, Si Double Fenestrated Grasper Instrument Product Name: da Vinci S, Si Double Fenestrated Grasper Instrument Model/Catalog Number: 420189 Software Version: NA Product Description: EndoWrist Instruments or Da Vinci S/Si Reusable instruments, including bl
Manufacturer
Intuitive Surgical, Inc.
Category
Medical Device — Robotic surgery
Hazard
Affected units
2,370

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot Code: 420189

Distribution

Distributed nationwide across the United States.

The notice also names 20 states specifically:

Part of a larger recall action

This product is one of 4 recalled by Intuitive Surgical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Related recalls

Same manufacturer · Intuitive Surgical, Inc.

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Same hazard · cable failure

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