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Recall

Brand Name: da Vinci S, Si Tenaculum Forceps Instrument Product Name: da Vinci S, Si Tenaculum Forceps Instrument Model/Catalog Number: 420207 Software Version: N/A Product Description: EndoWrist Instruments or Da Vinci S/Si Reusable…

Intuitive Surgical, Inc. · 9 Dec 2025

Status
Recall open, classified
Why, in the FDA's words
“Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments”
Recall began
9 Dec 2025
Company
Intuitive Surgical, Inc.
Device type
Robot-assisted surgical systems (computer-controlled instruments) (NAY)
Concerns
K050369

What it means

A recall is the FDA's record that a company is correcting or removing a device because of a problem. Many are fixed with a software update or new instructions; the record does not say whether anyone was hurt. See our plain guide to FDA terms.

The record

The FDA publishes this record in its public device database. The summary documents the company filed, when available, are linked from the FDA's page.
FDA database