The Recall Desk
HighFDA (Devices)·Z-0850-2025·Announced 2025-01-22

Intuitive Surgical Recalls 8MM Surgical Scissors for Grip Cable Defects

Intuitive Surgical is recalling 4,259 units of 8MM round tip scissors due to complaints of frayed or broken grip cables. The defect could affect instrument reliability during surgical procedures.

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 medical device recall with no reported injuries or hospitalizations. The hazard—frayed or broken grip cables—presents a risk-of-harm scenario affecting surgical instrument reliability, but no patient injuries have been documented in the source material.

Plain-English summary

Intuitive Surgical, Inc. is recalling 4,259 units of 8MM round tip scissors (Model 470007, part number 470007-05). These are reusable surgical instruments with round tips and moveable jaws designed for use in surgical procedures.

The recall was initiated due to increased complaints regarding frayed or broken grip cables on these instruments. Defective grip cables could affect the reliability and control of the instrument during surgical use.

The affected instruments were distributed nationwide throughout the United States and internationally to multiple countries including Canada, the United Kingdom, Germany, Japan, Australia, Brazil, Mexico, and numerous others across North America, South America, Europe, Asia, Africa, and the Middle East.

The recalled product

Product
8MM, ROUND TIP SCISSORS, IS4000 ¿ REF 470007
Manufacturer
Intuitive Surgical, Inc.
Category
Medical Device — Surgical Scissors
Hazard
  • grip-cable-defect

Distribution

Distribution scope not specified by the agency.

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