The Recall Desk
ModerateFDA (Devices)·Z-1975-2014·Announced 2014-07-09

Intuitive Surgical Recalls da Vinci Surgical System Quick Reference Guides

Intuitive Surgical is recalling Natural Rubber Latex Quick Reference Guides for the da Vinci Surgical System to update documentation and remove a specific wrench part.

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 and involves documentation updates and the removal of a specific tool part, which aligns with the rubric for moderate severity involving minor labeling or documentation issues without reported injuries.

Plain-English summary

Intuitive Surgical, Inc. is recalling Natural Rubber Latex Quick Reference Guides (QRG) 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) used with the da Vinci Surgical System, instruments, and accessories.

The recall is initiated to implement documentation updates and to remove the Emergency Grip Release Wrench, part number 710142. The affected products are identified by part number 551997. All units distributed prior to June 2014 are included in this recall.

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 the da Vinci Surgical System should consult the recall notice for specific instructions on how to update their documentation and handle the removed part.

The recalled product

Product
Natural Rubber Latex QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System . Intuitive Surgical Endoscopic Instrument Control System.
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 551997.

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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.

See all 12 products in this recall →