FDA Medical Device Recalls (openFDA)
Intuitive Surgical, Inc.: da Vinci Xi/X Tip-Up Fenestrated Grasper, REF: 470347, VER: 12
- Recall number
- Z-2059-2023
- Recalling firm
- Intuitive Surgical, Inc.
- Product
- da Vinci Xi/X Tip-Up Fenestrated Grasper, REF: 470347, VER: 12
- Status
- Open, Classified
- Initiated
- 2023-06-12
- Posted
- 2023-06-30
- Terminated
- not on file
- Reason
- 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
- 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 Recalls@intusurg.com 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: customerservice@intusurg.com. - Europe, Middle East, Asia and Africa: +800 0821 2020 or +41 21 821 2020 (8 AM to 6 PM CET) or ics@intusurg.com - 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
- 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.
- Lot, serial or model codes
- UDI-DI: 00886874112496, All Lots.
- 510(k) numbers
- ["K131861"]
- PMA numbers
- not on file
- Product code
- NAY
- Firm FEI
- 3001675293
- Firm city
- Sunnyvale
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28