The Recall Desk
HighFDA (Devices)·Z-0854-2025·Announced 2025-01-22

Prograsp Surgical Forceps Recalled Due to Frayed Grip Cables

Intuitive Surgical is recalling 2,852 units of 8MM Prograsp Forceps due to complaints of frayed or broken grip cables. These reusable surgical instruments may lose grip control during use.

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 involving mechanical failure of a surgical instrument's grip cables. Although no injuries or hospitalizations are reported, the hazard presents a risk of harm through potential loss of instrument control during surgical procedures.

Plain-English summary

Intuitive Surgical, Inc. is recalling approximately 2,852 units of 8MM Prograsp Forceps (Model 470093). These are reusable surgical forceps with jaws used in minimally invasive surgical procedures.

The company issued this recall due to increased complaints regarding frayed or broken grip cables on these instruments. The grip cables control the grasping function of the forceps.

The affected instruments were distributed nationwide across the United States and internationally to multiple countries. Healthcare facilities and surgical centers using these instruments should stop use immediately and contact Intuitive Surgical for instructions on obtaining replacement units.

The recalled product

Product
8MM,PROGRASP FORCEPS,IS4000 ¿ REF 470093
Manufacturer
Intuitive Surgical, Inc.
Category
Medical Device — Surgical Instruments
Hazard
  • cable-failure
  • grip-loss

Distribution

Distribution scope not specified by the agency.

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