Intuitive Surgical Recalls da Vinci 5 mm Instrument Cannulae for Inspection Changes
Intuitive Surgical is voluntarily modifying the inspection process for da Vinci 5 mm Instrument Cannulae used in surgical systems.
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 a voluntary precautionary action to modify an inspection process without reported injuries or specific defects cited in the source, fitting the criteria for a moderate severity voluntary recall.
Plain-English summary
Intuitive Surgical, Inc. is implementing a voluntary Field Action to modify the inspection process for the da Vinci 5 mm Instrument Cannulae (Part Numbers 420011 and 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 covers Model number 420011 and was distributed worldwide to 2,101 consignees. Distribution included the United States (nationwide) and the following countries: Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Netherlands, Norway, South Korea, Sweden, Switzerland, and the United Kingdom.
This action is classified as Class II by the FDA. The source text does not specify a particular defect or reported injuries, but indicates a change in the inspection process for the affected cannulae.
The recalled product
- Product
- da Vinci 5 mm 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 420011
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
See all →- ModerateIntuitive Surgical Recalls da Vinci 5 mm Flared Instrument Cannulae
FDA (Devices) · 2013-06-12