Intuitive Surgical Recalls da Vinci S User Manual for Sterile Adapter Instructions
Intuitive Surgical is recalling IS2000 user manuals for the da Vinci S system to provide revised instructions on sterile adapter engagement and instrument installation.
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 classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is theoretical, relating to documentation accuracy rather than a direct physical defect causing harm.
Plain-English summary
Intuitive Surgical, Inc. is recalling the IS2000 User Manual for the Intuitive Surgical da Vinci S Surgical System, Model IS2000. The recall involves 1,642 customers who received the manual, which is identified by model number 550516-05. The product was distributed worldwide, including in the United States and several countries in Europe and Asia.
The recall is being conducted to provide revised instructions for users of the da Vinci S, Si, and Si-e systems. The updated documentation includes additional information regarding sterile adapter engagement and instrument installation. The original manual describes arm drapes that protect equipment from contamination.
Customers who have received the IS2000 User Manual should contact Intuitive Surgical, Inc. for further instructions on how to obtain the revised documentation. This action is intended to ensure that users have the most current and accurate guidance for operating the surgical system.
The recalled product
- Product
- IS2000 USER MANUAL for Intuitive Surgical da Vinci S Surgical System, Model IS2000. Arm drapes protect equipment from contamination.
- Manufacturer
- Intuitive Surgical, Inc.
- Affected units
- 1,642
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 550516-05
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.
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