Intuitive Surgical Recalls 8mm Cannulas for Labeling Clarification
Intuitive Surgical is recalling 8mm cannulas to clarify existing labeling information and operating procedures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 for minor labeling errors and clarification of operating procedures, which aligns with the Moderate severity criteria for low-risk issues.
Plain-English summary
Intuitive Surgical, Inc. is recalling the Cannula 8MM Regular (Model number 420002-07). This medical device provides the means of introduction and placement of an instrument or accessory into the human body.
The recall is being conducted to clarify existing labeling information and operating procedures. The agency has classified this recall as Class II.
The affected products were distributed worldwide, including the USA and countries such as Argentina, Australia, Canada, Chile, China, Czech Republic, Egypt, India, Israel, Italy, Korea-Republic of, Poland, Qatar, Romania, Saudi Arabia, Singapore, Spain, Thailand, Turkey, and Venezuela.
The recalled product
- Product
- Cannula 8MM Regular. Provides the means of introduction and placement of an instrument or accessory into the human body.
- Manufacturer
- Intuitive Surgical, Inc.
- Hazard
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 420002-07
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 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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