The Recall Desk
HighFDA (Devices)·Z-0877-2025·Announced 2025-01-22

Intuitive Surgical Cobra Grasper Surgical Instruments Recalled for Cable Fraying

Intuitive Surgical is recalling 2,472 Cobra Grasper surgical instruments due to frayed or broken grip cables that may affect 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 recall of surgical instruments with a functional defect (frayed or broken grip cables) that presents a risk of harm during surgical use. No injuries or adverse outcomes are reported in the source material, meeting the rubric criterion for High (Score 3): 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

Intuitive Surgical, Inc. is recalling 2,472 units of its 8MM Cobra Grasper (Model 471190) surgical instruments with jaws. The recall is due to increased complaints regarding frayed or broken grip cables on the reusable instruments. Cable defects may impair proper functioning during surgical use.

The affected instruments were distributed throughout the United States, including all 50 states, the District of Columbia, and Puerto Rico. International distribution includes countries across Europe, Asia, the Americas, Australia, Africa, and the Middle East. Affected batch numbers are K10230226, K10230405, K10230413, K10230420, K10231005, K10231019, K10231130, K10240104, K10240111, K10240118, K10240327, K10240418, K10240502, K10240606, and K10240725.

Facilities and users with affected instruments should discontinue use and contact Intuitive Surgical for instructions on replacement or further guidance.

The recalled product

Product
8MM,COBRA GRASPER,IS4000 REF 471190
Manufacturer
Intuitive Surgical, Inc.
Category
Medical Device — Surgical Instrument
Hazard
  • cable-fraying
  • mechanical-failure

Distribution

Distribution scope not specified by the agency.

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