Intuitive Surgical Recalls Da Vinci Xi EndoWrist Monopolar Curved Scissors
Intuitive Surgical is recalling 286 Da Vinci Xi EndoWrist Monopolar Curved Scissors because they are not recognized by the integrated electrosurgical unit, preventing the activation of monopolar energy.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The defect prevents the activation of monopolar energy, which is a functional failure rather than a direct physical hazard like a fire or sharp edge. No injuries or illnesses are reported, and the risk is primarily the inability to perform the intended surgical function.
Plain-English summary
Intuitive Surgical, Inc. is recalling 286 units of the Da Vinci Xi/X EndoWrist Monopolar Curved scissors (MCS), model number 470179-19. The affected units are identified by serial numbers N11181003 and N11181004 and UDI (00) 886874112298.
The recall was initiated because the instruments are not recognized by the integrated electrosurgical unit. This defect prohibits the activation of monopolar energy from the surgeon console, rendering the instruments non-functional for their intended surgical use.
The affected products were distributed nationally across 38 U.S. states, including Alabama, Arizona, California, and Texas. No out-of-state distribution was reported. Healthcare facilities and consumers should stop using these specific instruments and contact Intuitive Surgical for further instructions.
The recalled product
- Product
- Da Vinci Xi/X EndoWrist Monopolar Curved scissors (MCS), model number 470179-19, UDI: (00) 886874112298
- Manufacturer
- Intuitive Surgical, Inc.
- Hazard
- Affected units
- 286
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Serial Number/Manufacturing Lot: N11181003
- N11181004
Distribution
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