The Recall Desk
HighFDA (Devices)·Z-0872-2025·Announced 2025-01-22

Reusable Surgical Forceps Recall Due to Frayed or Broken Grip Cables

Intuitive Surgical is recalling 1,562 units of 8mm surgical forceps (Model 471048) due to complaints of frayed or broken grip cables. The defect could impair instrument function 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 device recall without reported illnesses or injuries. The defect involves material degradation of grip cables on surgical instruments, a risk-of-harm product where injury has not yet been reported, meeting the rubric criterion for High severity.

Plain-English summary

Intuitive Surgical, Inc. is recalling 1,562 units of 8mm Long Tip Forceps (Model 471048) due to frayed or broken grip cables on the reusable instruments with jaws. The manufacturer has received increased complaints regarding this defect.

Frayed or broken grip cables could impair proper function of the instruments. The recalled forceps have been distributed nationwide throughout the United States and internationally to numerous countries. Healthcare facilities and surgical centers using these instruments should discontinue use and contact Intuitive Surgical for further guidance.

The recalled product

Product
8MM,LONG TIP FORCEPS,IS4000 REF 471048
Manufacturer
Intuitive Surgical, Inc.
Category
Medical Device — Surgical Instruments
Hazard
  • cable-fraying
  • instrument-malfunction

Distribution

Distribution scope not specified by the agency.

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