The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1967-2014·Announced 2014-07-09

Intuitive Surgical Recalls da Vinci Surgical System Instrument Release Kits

Intuitive Surgical is recalling Instrument Release Kits 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 and involves the removal of a specific component (Emergency Grip Release Wrench) from surgical kits. No injuries, illnesses, or deaths are reported in the source text, and the hazard appears to be a procedural or documentation update rather than a direct physical defect causing harm, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Intuitive Surgical, Inc. is recalling Instrument Release Kits (IRK) for the da Vinci Standard Surgical System, da Vinci S System, and da Vinci Si System. The recall involves the removal of the Emergency Grip Release Wrench, part number 710142, from these kits.

The recall covers all distributed units prior to June 2014. The affected products were distributed nationwide in the United States and internationally to numerous countries, including Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Germany, Great Britain, Greece, Guadeloupe, India, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Malaysia, Mexico, Monaco, Netherlands, New Zealand, Norway, Pakistan, Philippines, Portugal, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovak Republic, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Uruguay, Venezuela, and Vietnam.

The recall is associated with updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits. The specific action required is the removal of the Emergency Grip Release Wrench from the kits. Users should verify their part numbers and follow the instructions provided by the manufacturer regarding the removal of this specific component.

The recalled product

Product
Insert for IRK 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.
Category
Medical Device — Surgical Instruments
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 550973

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 →

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