The Recall Desk
HighFDA (Devices)·Z-1699-2026·Announced 2026-04-08

da Vinci grasping retractor instruments recalled over broken grip cables

Intuitive Surgical is recalling da Vinci S and Si Grasping Retractor 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 Grasping Retractor Instrument, model 420278. The EndoWrist reusable instruments are intended for endoscopic manipulation of tissue, including grasping, cutting, dissection, ligation, electrocautery and suturing, and use mechanical tungsten cables and pulleys to transmit motion from the input discs. About 2,660 units were distributed across 20 US states and more than thirty 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 carries GTIN 00886874111772, across the batch and system numbers listed in the FDA enforcement record.

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

The recalled product

Product
Brand Name: da Vinci S, Si Grasping Retractor Instrument Product Name: da Vinci S, Si Grasping Retractor Instrument Model/Catalog Number: 420278 Software Version: NA Product Description: EndoWrist Instruments or Da Vinci S/Si Reusable instruments, including blunt and sharp en
Manufacturer
Intuitive Surgical, Inc.
Category
Medical Device — Robotic surgery
Hazard
Affected units
2,660

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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