Intuitive Surgical 8mm Cadiere Forceps Recalled for Frayed Grip Cables
Intuitive Surgical is recalling 56,580 units of the 8mm Cadiere Forceps (Model 471049) due to increased complaints of frayed or broken grip cables on the reusable surgical instrument.
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 a reusable surgical instrument with a mechanical defect involving grip cables. The source text does not report any illnesses or injuries. Per the rubric, this qualifies as High (Score 3): a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Intuitive Surgical, Inc. is recalling 56,580 units of the 8mm Cadiere Forceps, Model 471049 (Reference 471049), a reusable surgical instrument with jaws. The recall was initiated due to increased complaints regarding frayed or broken grip cables.
The affected instruments were distributed nationwide across the United States and internationally to numerous countries. Specific affected batch numbers are available through the FDA.
The recalled product
- Product
- 8MM,CADIERE FORCEPS,IS4000 REF 471049
- Manufacturer
- Intuitive Surgical, Inc.
- Hazard
- cable-failure
- mechanical-defect
Distribution
Distribution scope not specified by the agency.
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