The Recall Desk
HighFDA (Devices)·Z-0871-2025·Announced 2025-01-22

Intuitive Surgical 8MM Force Bipolar Instruments Recalled for Frayed Grip Cables

Intuitive Surgical, Inc. is recalling 8MM Force Bipolar surgical instruments due to increased complaints of frayed or broken grip cables on the 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: This is FDA Class II with no reported hospitalizations or injuries, only complaints of mechanical defect. Per the rubric, risk-of-harm medical devices where injury has not yet been reported receive a score of 3 (High).

Plain-English summary

Intuitive Surgical, Inc. is recalling 8MM Force Bipolar surgical instruments due to increased complaints of frayed or broken grip cables on the reusable instrument jaws. The recalled batch number is K10230713 (Model 470405).

The affected instruments have been distributed nationwide throughout the United States and internationally. The specific issue is fraying or breakage of the grip cables on the reusable instruments.

The FDA classified this as a Class II recall. Facilities using these instruments should contact Intuitive Surgical, Inc. or consult the FDA recall information for instructions on product replacement or return.

The recalled product

Product
8MM,FORCE BIPOLAR,IS4000 REF 470405
Manufacturer
Intuitive Surgical, Inc.
Category
Medical Device — Surgical Instrument
Hazard
  • cable-fraying
  • cable-breakage

Distribution

Distribution scope not specified by the agency.

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