Intuitive Surgical Recalls da Vinci 5 mm Flared Instrument Cannulae
Intuitive Surgical is voluntarily recalling da Vinci 5 mm Flared Instrument Cannulae to implement a modified inspection process.
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 source describes a voluntary Field Action to modify an inspection process without reporting injuries, illnesses, or specific defects, fitting the criteria for a voluntary precautionary recall.
Plain-English summary
Intuitive Surgical, Inc. is implementing a voluntary Field Action for the da Vinci 5 mm Flared Instrument Cannulae (Model number 420262). These devices are used with the da Vinci S and Si Surgical Systems to establish a port of entry for Intuitive Surgical EndoWrist instruments.
The recall is being conducted to implement a modified inspection process for the 5 mm Cannula (PN 420011) and 5 mm Flared Cannula (PN 420262). The source text does not specify a particular defect, injury, or illness associated with this action.
The affected products were distributed worldwide, including nationwide in the United States and in Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Netherlands, Norway, South Korea, Sweden, Switzerland, and the United Kingdom. A total of 2,101 consignees received the product. The source text does not provide specific instructions for consumers or healthcare providers on how to respond to this field action.
The recalled product
- Product
- da Vinci 5 mm Flared Instrument Cannulae for use with the da Vinci S and Si Surgical Systems. Used to establish a port of entry for Intuitive Surgical EndoWrist instruments
- Manufacturer
- Intuitive Surgical, Inc.
- Hazard
- Affected units
- 2,101
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 (1)
- Model number 420262
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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.
See all 2 products in this recall →Related recalls
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Same hazard · inspection process
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