Intuitive Surgical Recalls da Vinci Stapler Addendum Documentation
Intuitive Surgical is recalling documentation for the da Vinci Surgical System stapler addendum to remove references to the Emergency Grip Release Wrench.
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 but involves documentation updates rather than a physical defect causing injury, fitting the criteria for minor labeling or documentation issues.
Plain-English summary
Intuitive Surgical, Inc. is recalling the Stapler Addendum for the da Vinci Standard Surgical System, da Vinci S System, and da Vinci Si System. The recall involves multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments, and accessories.
The reason for the recall is the removal of the Emergency Grip Release Wrench, part number 710142, from the documentation. This action affects all distributed units prior to June 2014. The affected products were distributed worldwide, including in the United States and numerous international locations.
Healthcare facilities and users should review the recall notice for specific instructions on updating their documentation. The recall is classified as Class II by the FDA, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Stapler Addendum for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.
- Manufacturer
- Intuitive Surgical, Inc.
- Hazard
- Affected units
- 2,014
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)
- Part number 550986
Distribution
Part of a larger recall action
This product is one of 12 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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