CLASS II Device recall · Reported 9 Jul 2014 · FDA Enforcement Report

Endowrist Instrument and Accessory Manual recalled by Intuitive Surgical

Intuitive Surgical is recalling Endowrist Instrument and Accessory Manual for the da Vinci Standard Surgical System, distributed nationwide in the US. The recall was initiated on 21 May 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPart number 550675

Quantity recalledAll distributed prior to June 2014

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1965-2014
FDA event ID: 68472
Recalling firm: Intuitive Surgical, Sunnyvale, CA
Classification: Class II
Status: Terminated
Recall initiated: 21 May 2014
FDA classified: 1 Jul 2014
Reported: 9 Jul 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

21 May 2014	Recall initiated by company
1 Jul 2014	Classified by FDA	+41 days
9 Jul 2014	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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. Removal of the Emergency Grip Release Wrench, part number 710142.

Product as listed by the FDA

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.

Where it was distributed

Worldwide Distribution - USA (nationwide) and Internationally to 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, Indonesia, 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.

Nationwide Puerto Rico

Questions about this recall

Is Endowrist Instrument and Accessory Manual for the da Vinci Standard Surgical System recalled?

Yes. Intuitive Surgical recalled Endowrist Instrument and Accessory Manual for the da Vinci Standard Surgical System on 21 May 2014. The recall is Class II and its status is Terminated. Recall number Z-1965-2014.

Why was it recalled?

Which lots are affected?

Part number 550675

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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