Changeflow GovPing Healthcare Intuitive Surgical da Vinci Cautery Hook Class ...
Priority review Enforcement Amended Final

Intuitive Surgical da Vinci Cautery Hook Class II Recall

Favicon for changeflow.com FDA: Device Recalls Class II
Filed
Detected
Email

Summary

Intuitive Surgical, Inc. initiated a Class II recall of the da Vinci S, Si Permanent Cautery Hook Instrument (Catalog #420183) due to increased complaints of frayed or broken pitch cables on reusable surgical instruments. The recall affects devices distributed nationwide across 24 U.S. states. The recall status is ongoing as of April 8, 2026.

What changed

Intuitive Surgical issued a Class II recall for its da Vinci S, Si Permanent Cautery Hook Instrument due to reports of frayed or broken pitch cables in reusable surgical instruments. The recall affects catalog number 420183 distributed across 24 U.S. states. This is an ongoing enforcement action.\n\nHealthcare providers using these surgical instruments should immediately identify affected inventory, discontinue use, and contact Intuitive Surgical for return or replacement instructions. The defective cables may compromise surgical precision during procedures.

What to do next

  1. Identify da Vinci S, Si Permanent Cautery Hook Instrument (Catalog #420183) in inventory
  2. Discontinue use of affected instruments
  3. Contact Intuitive Surgical for return/replacement instructions

Archived snapshot

Apr 14, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

Intuitive Surgical, Inc.

Device Recalls (Class II)

← All Device Recalls (Class II) Class II Z-1701-2026 · 20260408 · Ongoing

Product

Brand Name: da Vinci S, Si Permanent Cautery Hook Instrument Product Name: da Vinci S, Si Permanent Cautery Hook Instrument Model/Catalog Number: 420183 Software Version: NA Product Description...

Reason for Recall

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

Distribution

U.S. Nationwide distribution in the states of AR, CA, CT, FL, IA, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NJ, NM, NY, NC, OH, PA, TX, VA, and WA. T...

Source: openFDA Enforcement API

Get daily alerts for FDA: Device Recalls Class II

Daily digest delivered to your inbox.

Free. Unsubscribe anytime.

About this page

What is GovPing?

Every important government, regulator, and court update from around the world. One place. Real-time. Free. Our mission

What's from the agency?

Source document text, dates, docket IDs, and authority are extracted directly from FDA.

What's AI-generated?

The summary, classification, recommended actions, deadlines, and penalty information are AI-generated from the original text and may contain errors. Always verify against the source document.

Last updated

Classification

Agency
FDA
Filed
April 8th, 2026
Instrument
Enforcement
Legal weight
Binding
Stage
Final
Change scope
Substantive

Who this affects

Applies to
Medical device makers Healthcare providers
Industry sector
3345 Medical Device Manufacturing
Activity scope
Surgical instrument recall Device safety response
Geographic scope
United States US

Taxonomy

Primary area
Medical Devices
Operational domain
Clinical Operations
Compliance frameworks
GxP
Topics
Product Safety Healthcare

Get alerts for this source

We'll email you when FDA: Device Recalls Class II publishes new changes.

Free. Unsubscribe anytime.

You're subscribed!