Intuitive Surgical Recalls Cautery QRG for da Vinci Surgical Systems
Intuitive Surgical is recalling Cautery Quick Reference Guides for da Vinci systems to update documentation and remove a specific wrench part.
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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The source text describes documentation updates and the removal of a specific wrench part, which aligns with the 'Moderate' severity criteria for minor labeling or documentation issues without reported injuries.
Plain-English summary
Intuitive Surgical, Inc. is recalling Cautery Quick Reference Guides (QRG) for the da Vinci Standard Surgical System, da Vinci S System, and da Vinci Si System. The recall involves all units distributed prior to June 2014. The product is identified by part number 551992.
The recall is initiated to implement multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) used with the da Vinci Surgical System, instruments, and accessories. Additionally, the recall addresses the removal of the Emergency Grip Release Wrench, part number 710142.
The affected products were distributed worldwide, including nationwide in the United States and internationally to numerous countries such as Argentina, Australia, Canada, China, France, Germany, Japan, and the United Kingdom. Users of these surgical systems should refer to the updated documentation provided by the manufacturer.
The recalled product
- Product
- Cautery QRG 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.
- 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 551992.
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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