The Recall Desk
HighFDA (Devices)·Z-0860-2025·Announced 2025-01-22

Intuitive Surgical Tenaculum Forceps Recalled for Frayed or Broken Grip Cables

Intuitive Surgical is recalling 11,162 units of 8MM Tenaculum Forceps (Model 470207) due to increased complaints of frayed or broken grip cables on reusable surgical instruments. Users should discontinue use immediately.

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: This is an FDA Class II recall for a surgical instrument with a functional defect (frayed or broken grip cables) that presents a risk of harm during surgical procedures. No injuries or hospitalizations have been reported in the source text.

Plain-English summary

Intuitive Surgical, Inc. is recalling 11,162 units of 8MM Tenaculum Forceps with model number 470207 and part number 470207-10. This is a Class II recall issued by the U.S. Food and Drug Administration.

The recall was initiated due to increased complaints regarding frayed or broken grip cables on the reusable surgical instruments. These cables are critical components for proper instrument operation during surgical procedures.

The recalled instruments have been distributed nationwide throughout the United States and internationally to countries including Canada, the United Kingdom, Germany, France, Japan, Australia, and many others.

Affected customers and healthcare facilities should immediately discontinue use of the recalled instruments and contact Intuitive Surgical, Inc. for further instructions regarding replacement or corrective measures.

The recalled product

Product
8MM,TENACULUM FORCEPS,IS4000¿ REF 470207
Manufacturer
Intuitive Surgical, Inc.
Category
Medical Device — Surgical Instruments
Hazard
  • grip-cable-failure
  • surgical-instrument-malfunction

Distribution

Distribution scope not specified by the agency.

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