Surgical Forceps Recalled for Frayed or Broken Grip Cables
Intuitive Surgical is recalling 373 Resano Forceps due to increased complaints of frayed or broken grip cables on the reusable surgical instruments. Affected healthcare providers should contact the manufacturer for guidance.
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 Class II medical device recall involves functional failures of surgical forceps where grip cables may fray or break, creating a risk of instrument malfunction during surgical procedures. No injuries or illnesses have been reported, placing this in the 'risk-of-harm products where injury has not yet been reported' category.
Plain-English summary
Intuitive Surgical, Inc. is recalling 8MM Resano Forceps (Model 470181) instruments due to increased complaints regarding frayed or broken grip cables on these reusable surgical instruments. A total of 373 units are affected.
The recalled instruments were distributed nationwide throughout the United States and internationally to over 65 countries, including Canada, Australia, Japan, Mexico, and the United Kingdom.
Healthcare providers and facilities that have received these instruments should contact Intuitive Surgical, Inc. for further information and guidance regarding this recall.
The recalled product
- Product
- 8MM,RESANO FORCEPS,IS4000 ¿ REF 470181
- Manufacturer
- Intuitive Surgical, Inc.
- Affected units
- 373
Distribution
Part of a larger recall action
This product is one of 37 recalled by Intuitive Surgical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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