The Recall Desk
HighFDA (Devices)·Z-0848-2025·Announced 2025-01-22

Surgical Scissors Recalled for Frayed or Broken Grip Cables

Intuitive Surgical is recalling 8MM Potts Scissors due to frayed or broken grip cables that could affect instrument performance 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 for a surgical instrument with confirmed mechanical defects (frayed or broken grip cables). While no injuries or hospitalizations have been reported, surgical scissors are risk-of-harm devices where equipment failure could affect procedure safety.

Plain-English summary

Intuitive Surgical, Inc. is recalling the 8MM Potts Scissors (Model 470001) due to increased complaints regarding frayed or broken grip cables on the reusable instruments. The grip cables are a critical component that affects the functionality and safety of the scissors during surgical procedures.

Approximately 3,625 units have been distributed nationwide across the United States, Puerto Rico, and internationally. The affected batch numbers are K10230308, K11230308, and K10230517. Healthcare facilities and surgical centers that have received these instruments should stop using them immediately.

Patients and healthcare providers who have used or are currently using these scissors should contact their healthcare facility or Intuitive Surgical for instructions on device return and replacement. While no injuries have been reported to date, continued use of instruments with compromised grip cables could pose a risk during surgical procedures.

The recalled product

Product
8MM, POTTS SCISSORS, IS4000 REF 470001
Manufacturer
Intuitive Surgical, Inc.
Category
Medical Device — Surgical Instruments
Hazard
  • frayed-cables
  • equipment-malfunction

Distribution

Distribution scope not specified by the agency.

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