Z-2059-2023Class II

da Vinci Xi/X Tip-Up Fenestrated Grasper, REF: 470347, VER: 12

Name: Z-2059-2023 da Vinci Xi/X Tip-Up Fenestrated Grasper, REF: 470347, VER: 12
Creator: Intuitive Surgical, Inc.
Published: 2023-06-12
License: https://open.fda.gov/license/

Intuitive Surgical, Inc. / initiated 2023-06-12 / Open, Classified / root cause: manufacturing process

FDA source

Intuitive Surgical, Inc. began a recall of da Vinci Xi/X Tip-Up Fenestrated Grasper, REF: 470347, VER: 12 on 2023-06-12. FDA classified it as Class II and gives the reason as "Fenestrated Graspers have a manufacturing issue has the potential to cause breakage on both upper and/or lower grips, which could lead to stainless steel fragments falling into the patient that may be either detected or...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2059-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-06-12
Posted: 2023-06-30
Recalling firm: Intuitive Surgical, Inc.
Product: da Vinci Xi/X Tip-Up Fenestrated Grasper, REF: 470347, VER: 12
Product code: NAY System, Surgical, Computer Controlled Instrument
Reason for recall: Fenestrated Graspers have a manufacturing issue has the potential to cause breakage on both upper and/or lower grips, which could lead to stainless steel fragments falling into the patient that may be either detected or undetected.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 6/12/23 Field Safety Notices were mailed and emailed to customers asking them to do the following: 1) Locate and return affected devices. 2) Notify all surgeons and users of the device about the contents of the notice. 3) Complete and return the acknowledgement form to [email protected] If you need further information or support concerning this Medical Device Notification, please contact your Clinical Sales Representative or contact Customer Service at: - North and South America: (800) 876-1310, Option 3 (4 AM to 5 PM PST) or mail: [email protected]. - Europe, Middle East, Asia and Africa: +800 0821 2020 or +41 21 821 2020 (8 AM to 6 PM CET) or [email protected] - South Korea: 02-3271-3200 (9 AM to 6 PM KSTJ) - Japan: 0120-56-5635 or 03-5575-1362 (9 AM to 6 PM JST) - India: +1-800-103-6952 (9 AM to 6 PM IT) - Taiwan: +0800-86-8181 (9 AM to 6 PM CT)
Quantity in commerce: 46,033
Distribution: Worldwide - US Nationwide distribution in the states of PR, FL, MN, PA, AZ, OH, IL, NC, GA, KS, CA, HI, MD, OR, SC, AK, NY, NE, IA, WA, OK, ND, UT, MS, AR, WI, MI, TX, TN, IN, NJ, VA, SD, CO, KY, AL, MO, LA, DE, MA, MT, WV, ID, CT, NV, NH, ME, WY, DC, RI, NM, VT and the countries of Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Cyprus, Czech Republic, Denmark, Dominican Republic, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Luxembourg, Mexico, Monaco, Netherlands, Norway, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom.
Product codes and lots: UDI-DI: 00886874112496, All Lots.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2059-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2059-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-12	2023-06-30

Product code NAY

K131861Class IIDa Vinci Surgical System, Endowrist Instruments and AccessoriesIntuitive Surgical, Inc. / cleared 2014-03-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)