Intuitive Surgical Recalls da Vinci Endowrist Instrument Manuals
Intuitive Surgical is recalling Endowrist Instrument and Accessory Manuals for the da Vinci Surgical System to remove the Emergency Grip Release Wrench.
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 a documentation update and the removal of a specific wrench part, without reporting any injuries, illnesses, or deaths.
Plain-English summary
Intuitive Surgical, Inc. is recalling the Endowrist Instrument and Accessory Manual for the da Vinci Standard, S, and Si Surgical Systems. The recall involves multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK). The specific action taken is the removal of the Emergency Grip Release Wrench, part number 710142.
The affected products are identified by part number 550675 and include all units distributed prior to June 2014. The distribution was worldwide, covering the United States and numerous international locations including Argentina, Australia, Canada, China, France, Germany, Japan, and the United Kingdom.
This recall is classified as Class II by the FDA. Users of the da Vinci Surgical System should check their documentation for the presence of the Emergency Grip Release Wrench and follow the manufacturer's instructions for updating their manuals and kits.
The recalled product
- Product
- Endowrist Instrument and Accessory Manual 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 550675
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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