Intuitive Surgical Micro Forceps Recalled Due to Grip Cable Defects
Intuitive Surgical is recalling 8MM Black Diamond Micro Forceps (Model 470033) due to complaints of frayed or broken grip cables. The defect affects 1,111 units distributed nationwide and internationally.
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 surgical instrument with a documented defect (frayed or broken grip cables). While the defect poses a risk of harm during surgical procedures due to potential loss of instrument control, no injuries or hospitalizations have been reported in the source material. The score reflects the risk-of-harm nature of the product defect in the absence of reported adverse events.
Plain-English summary
Intuitive Surgical, Inc. is recalling 8MM Black Diamond Micro Forceps (Model 470033) due to reports of frayed or broken grip cables on the reusable instruments. The defect affects 1,111 units distributed nationwide across all U.S. states and territories, plus over 40 countries internationally.
The recall involves Model 470033 with Part Numbers 470033-09 and 470033-11. Affected batch numbers include K10230219, K10230316, K10230511, K10230615, K10230706, K10230713, K10230824, K10230928, K10231005, K10231109, K10231218, K10240104, K10240229, K10240418, K10240613, and K10230914.
Healthcare facilities and surgical teams using affected forceps should discontinue use immediately and contact Intuitive Surgical for replacement or further guidance.
The recalled product
- Product
- 8MM,BLACK DIAMOND MICRO FORCEPS,IS4000 ¿ REF 470033
- Manufacturer
- Intuitive Surgical, Inc.
- Hazard
- grip-cable-failure
- loss-of-grip
Distribution
Distribution scope not specified by the agency.
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