The Recall Desk
HighFDA (Devices)·Z-0874-2025·Announced 2025-01-22

ProGrasp Forceps Recalled Due to Frayed or Broken Grip Cables

Intuitive Surgical recalls ProGrasp Forceps instruments due to increased complaints of frayed or broken grip cables. Approximately 99,249 units distributed in the U.S. and internationally are affected.

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: FDA Class II medical device with documented complaints of mechanical failure (frayed or broken cables) on surgical instruments. Per the severity rubric, this constitutes a risk-of-harm product where injury has not yet been reported, warranting severity level 3 (High).

Plain-English summary

Intuitive Surgical, Inc. is recalling 8MM ProGrasp Forceps (Model 471093) due to increased complaints of frayed or broken grip cables on these reusable surgical instruments. The grip cables are a critical component that enables proper jaw and grasping function during surgical procedures.

The affected instruments were distributed nationwide in the United States and to international locations. A total of 99,249 units are included in this recall. Specific batch numbers affected are identified by the manufacturer.

Healthcare facilities and surgical centers should verify the batch numbers of their ProGrasp Forceps instruments against the official recall notice. Affected units should not be used and should be removed from service immediately. Contact Intuitive Surgical for guidance on replacement, repair, or other remediation options.

The recalled product

Product
8MM,PROGRASP FORCEPS,IS4000 REF 471093
Manufacturer
Intuitive Surgical, Inc.
Category
Medical Device — Surgical Instrument
Hazard
  • cable-failure
  • malfunction

Distribution

Distribution scope not specified by the agency.

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